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Adverse Event Report

ALLEGIANCE HEALTHCARE CORP. LATEX EXAM GLOVES   back to search results
Event Date 11/11/1992
Event Type  Other   Patient Outcome  Other;
Event Description

Plantiff alleges sensitization to latex and is at risk of suffering anaphylactic reactions when in contact with natural latex. Further alleges experiencing rhinitis, conjuctivitis and full-blown anaphylaxis with severe broncho-constriction, generalized urticaria, full body excema and hives and dyspnea.

 
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.

 
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Brand NameLATEX EXAM GLOVES
Type of DeviceEXAM 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 (Section G)
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
1430 waukegan rd.
mcgaw park IL 60085
Device Event Key100229
MDR Report Key101843
Event Key95733
Report Number1423537-1997-00103
Device Sequence Number1
Product CodeLYY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 07/01/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
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 Report TO Manufacturer06/06/1997
Date Manufacturer Received06/06/1997
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 Invalid Data

Database last updated on February 28, 2009

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