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Adverse Event Report

ALLEGIANCE HEALTHCARE CORPORATION LATEX EXAM GLOVES   back to search results
Event Date 08/21/1997
Event Type  Other   Patient Outcome  Other;
Event Description

The plaintiff suffered from inter alia urticaria, hand dermatitis, allergic rhinitis, itchy and watery eyes, chest congestion, and dyspnea (wheezing and asthma). Plaintiff has been diagnosed as suffering from type-i latex allergy. Plaintiff is at risk for suffering anaphylactic reactions when plaintiff comes into contact with many different commonly used products which contain the natural latex protein. Plaintiff has suffered severe and irreversible latex allergy. Plaintiff is restricted from entering any environment where plaintiff is exposed to latex protein. Plaintiff alleges entering such environments puts plaintiff at serious risk for anaphylactic reaction. Plaintiff must have life in constant vigilance for the presence of latex products, avoiding everyday common products that contain latex. Plaintiff is restricted in life as to where plaintiff can go, and what plaintiff can do with life, with career, and with family. Plaintiff finds it difficult to seek medical and dental care, and entering a non-latex safe environment in a hospital, for any purpose, is a health hazard. Plaintiff has further suffered and will continue to suffer in the future, emotional distress, and an inability to engage in normal activities. Plaintiff has suffered physical injuries, including but not limited to urticaria, hives, allergic rhinitis, itchy and watery eyes, and dyspnea, and other physical injuries, as well as despair, and loss of enjoyment of life, all of which are of a permanent and continuing and life threatening nature, and other damages. Plaintiff has suffered great loss and depreciation of earning capacity and will continue to suffer same for an indefinite time in the future.

 
Manufacturer Narrative

No catalog number nor lot number was provided by the reporter, therefore an investigation cannot be performed. Litigation pending. No customer contact allowed.

 
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Brand NameLATEX EXAM GLOVES
Type of DeviceLATEX EXAM GLOVES
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALLEGIANCE HEALTHCARE CORPORATION
1500 waukegan road
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE CORPORATION
1500 waukegan road
mcgaw park IL 60085
Manufacturer Contact
patricia sharpe-gregg
1500 waukegan road
mcgaw park , IL 60085
(847) 578 -3636
Device Event Key287291
MDR Report Key296792
Event Key278769
Report Number1423507-2000-00229
Device Sequence Number1
Product CodeLYY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 09/18/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2000
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 Received08/28/2000
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 06, 2009

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