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Adverse Event Report

BARD BARD SINGULAR POLYP SNARE COLON POLYP SNARE   back to search results
Lot Number 88LMO335
Patient Outcome  Other;
Event Description

Pt had a perforated bowel after a colonoscopy. Potentially it is thought the polyp snare used could have caused the perforation. The snares have been returned to the co for evaluation.

 
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Brand NameBARD SINGULAR POLYP SNARE
Type of DeviceCOLON POLYP SNARE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BARD
8195 industrial blvd.
covington GA 30014
Device Event Key466054
MDR Report Key477251
Event Key452317
Report NumberMW1029204
Device Sequence Number1
Product CodeFDI
Report Source Voluntary
Report Date 08/04/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device LOT Number88LMO335
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/10/2003
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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