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Adverse Event Report

BAXTER SURGICAL GROUP LATEX EXAM GLOVES   back to search results
Event Date 06/27/1996
Event Type  Injury  
Event Description

Plaintiff alleges suffering and will suffer great pain of body and anguish of mind, reduced earning capacity.

 
Manufacturer Narrative

The investigation could not be performed as the reporter did not provide any product identification or lot number info. Litigation pending, no customer contact allowed.

 
Search Alerts/Recalls

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Brand NameLATEX EXAM GLOVES
Type of DeviceEXAM GLOVES
Baseline Brand NameLATEX EXAM GLOVES
Baseline Catalogue NumberUNKNOWN
Baseline Model NumberUNKNOWN
Baseline Device FamilyLATEX GLOVES
Baseline Device 510(K) NumberK892750
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed07/14/1989
Manufacturer (Section F)
BAXTER SURGICAL GROUP
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MALAYSIA
Manufacturer (Section D)
BAXTER SURGICAL GROUP
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penang
MALAYSIA
Manufacturer (Section G)
CARDINAL HEALTH MALAYSIA 211 SDN.BHD
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MALAYSIA 11900
Manufacturer Contact
michele donatich
1500 waukegan rd
mcgaw park , IL 60085
(847) 785 -3309
Device Event Key37076
MDR Report Key40054
Event Key33519
Report Number8040568-1996-00062
Device Sequence Number1
Product CodeLYY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation ATTORNEY
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/1996
Is This An Adverse Event 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
Event Location Invalid Data
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 30, 2009

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