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Adverse Event Report

ETHICON, INC. COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE   back to search results
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 05/01/1994
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

It was reported that the pt had a history of several abdominal surgeries related to diverticular disease and was admitted in 1994 for repair of ventral and umbilical hernias. During surgery, an enterotomy was inadvertently made into the transverse colon. Postoperatively the pt developed significant nausea and vomiting and was subsequently found to have a large purulent wound infection. This was drained non-surgically in 5/1994, cultures were sent and pt was started on daily dressing changes and iv antibiotics. The pt improved markedly and pt was discharged for home health care dressing changes six days later.

 
Manufacturer Narrative

H-6 conclusion: since there is no product available for eval and the product lot number is unk, the investigation of this complaint is limited and co is unable to draw a conclusion.

 
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Brand NameCOATED VICRYL (POLYGLACTIN 910) SUTURE
Type of DeviceSUTURE, ABSORBABLE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ETHICON, INC.
route 22 west
p.o. box 151
somerville NJ 08876 0151
Manufacturer (Section D)
ETHICON, INC.
route 22 west
p.o. box 151
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON, INC. SAN ANGELO
3348 pulliam st
san angelo TX 76905 4403
Manufacturer Contact
mark yale
route 22 west
p.o. box 151
somerville , NJ 08876-0151
(908) 218 -2326
Device Event Key523189
MDR Report Key533921
Event Key506949
Report Number2210968-2004-00380
Device Sequence Number1
Product CodeGAM
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 06/16/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Manufacturer Received06/16/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Database last updated on January 30, 2009

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