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Adverse Event Report

ALLEGIANCE HEALTHCARE LATEX EXAM GLOVES   back to search results
Event Date 03/01/1997
Event Type  Other   Patient Outcome  Other;
Event Description

Plaintiff alleges latex sensitization and as a result suffers from asthma, shortness or breath, rhinitis, respiratory problems, tightness in the chest, dizziness, skin rashes, hives, contact dermatitis, urticaria, extreme discomfort, depression and emotional distress, all of which are or may be of a permanent continuing and life-threatening nature. Further alleges suffering considerable mental anguish, limitation and restriction of his usual activities, pursuits and pleasures, and may suffer substantial loss or earnings and earning capacity, and has been forced to expend sums of money for medical care and treatment and will continue to be caused to expend such indefinitely into the future.

 
Manufacturer Narrative

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

 
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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
1500 waukegan rd.
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE
1500 waukegan rd.
mcgaw park IL 60085
Manufacturer (Section G)
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
1430 waukegan rd.
mcgaw park IL 60085
Device Event Key132225
MDR Report Key135335
Event Key127259
Report Number1423537-1997-00256
Device Sequence Number1
Product CodeLYY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 12/02/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/21/1997
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown

Database last updated on December 31, 2008

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