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Adverse Event Report

ETHICON, INC. SAN LORENZO ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NON-ABSORBABLE   back to search results
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 12/22/1994
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Pt reported an infection to facility. Medical records review indicated a suture abscess had developed in a previous incision. The abscess was incised and drained and the sutures were removed. The pt reportedly did well following this procedure.

 
Manufacturer Narrative

Sent to fda: 12/23/1999. H-6: conclusion: since there is no product available for evaluation and the product lot number is unknown, the investigation of this complaint is limited and co is unable to draw a conclusion. Should add'l info become available, a supplemental 3500a will be submitted.

 
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Brand NameETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Type of DeviceSUTURE, NON-ABSORBABLE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ETHICON, INC. SAN LORENZO
road 183, km 8.3
industrial area
hato PR 00754
Manufacturer (Section D)
ETHICON, INC. SAN LORENZO
road 183, km 8.3
industrial area
hato PR 00754
Manufacturer (Section G)
ETHICON, INC. SAN LORENZO
road 183, km. 8.3
industrial area
hato PR 00754
Manufacturer Contact
berkley pollard
route 22 west
po box 151
somerville , NJ 08876-0151
(908) 218 -2005
Device Event Key247659
MDR Report Key255764
Event Key239715
Report Number2210968-1999-00588
Device Sequence Number1
Product CodeGAS
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 11/12/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/1999
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
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Unknown
Date Manufacturer Received11/12/1999
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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