|
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.
|
|
Search Alerts/Recalls
|
|
|
Brand Name | BARD SINGULAR POLYP SNARE |
Type of Device | COLON POLYP SNARE |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section D) |
BARD |
8195 industrial blvd. |
covington GA 30014 |
|
Device Event Key | 466054 |
MDR Report Key | 477251 |
Event Key | 452317 |
Report Number | MW1029204 |
Device Sequence Number | 1 |
Product Code | FDI |
Report Source |
Voluntary
|
Report Date |
08/04/2003 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 08/04/2003 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device LOT Number | 88LMO335 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 07/10/2003 |
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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