FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule

Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

ALLEGIANCE HEALTHCARE CORP. LATEX EXAM GLOVES   back to search results
Event Date 03/13/2001
Event Type  Other   Patient Outcome  Other;
Event Description

The plaintiff alleges that while employed as a registered nurse the plaintiff was repeatedly exposed to fibers, particles and dusts from latex gloves. The plaintiff alleges that plaintiff experienced symptoms of an allergic reaction to latex gloves, which symptoms included shortness of breath and other respiratory symptoms which prevented the plaintiff from usual and customary duties as a ccu nurse. The plaintiff further alleges that the plaintiff was exposed to and did inhale loose particles, fibers and dust of latex materials causing the plaintiff to suffer significant injury and allergic reaction. Furthermore the plaintiff alleges that plaintiff was forced to endure physical pain and suffering, loss of life's pleasures, embarrassment and humiliation as a result of the plaintiff's hazardous exposure to the latex materials. The plaintiff alleges that plaintiff was forced to incur medical expenses to treat the symptoms brought on by the plaintiff's exposure to latex dust fiber and particles. Also the plaintiff alleges that plaintiff was forced to leave the plaintiff's job due to ongoing symptoms caused by the plaintiff's exposure to latex, all to plaintiff's corresponding financial loss and detriment. Finally, the plaintiff's spouse, alleges plaintiff's spouse has been deprived the society, companionship and consortium of plaintiff's spouse.

 
Manufacturer Narrative

No catalog number or lot number was provided by the reporter therefore an investigation cannot be performed. Litigation pending. No customer contact allowed.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameLATEX EXAM GLOVES
Type of DeviceLATEX EXAM GLOVES
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALLEGIANCE HEALTHCARE CORP.
1500 waukegan rd.
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE CORP.
1500 waukegan rd.
mcgaw park IL 60085
Manufacturer Contact
patricia sharpe-gregg
1500 waukegan road
mcgaw park , IL 60085
(847) 578 -4148
Device Event Key317696
MDR Report Key328312
Event Key308960
Report Number1423507-2001-00117
Device Sequence Number1
Product CodeLYY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 04/20/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/23/2001
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device? Unknown
Type of Device Usage Unkown

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH