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Adverse Event Report

ETHICON, INC. SAN LORENZO PROLENE POLYPROPYLENE MESH MESH/ENDOS   back to search results
Catalog Number PHSM
Device Problem Premature explantation
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

It was reported that six months post postoperatively, the pt was re-admitted with severe groin pain. Laparoscopy showed adhesion from sigmoid appendix epiploia to internal ring; this was divided with subsequent loss of symptoms. This occurred during a clinical trial.

 
Manufacturer Narrative

Sent to fda 5/5/1999. Multiple unsuccessful attempts have been made to obtain info regarding this event. At this time, co is unable to draw a conclusion regarding the cause for this event.

 
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Brand NamePROLENE POLYPROPYLENE MESH
Type of DeviceMESH/ENDOS
Baseline Brand NamePROLENE (POLYPROPYLENE) SUTURE
Baseline Generic NameSUTURE, NON-ABSORBABLE
Baseline Catalogue NumberPHSM
Baseline Device FamilyPROLENE POLYPROPYLENE SUTURE
Baseline Device 510(K) Number
Baseline Device PMA NumberN16374
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed04/01/1969
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.
route 22 west
somerville NJ 08876 0151
Manufacturer Contact
berkley pollard
route 22 west
somerville , NJ 08876-0151
(908) 218 -2005
Device Event Key215085
MDR Report Key221789
Event Key208111
Report Number2210968-1999-00262
Device Sequence Number1
Product CodeGAW
Report Source Manufacturer
Source Type Foreign
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 11/20/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/31/2003
Device Catalogue NumberPHSM
Device LOT NumberLA7137
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Home
Date Manufacturer Received11/20/1998
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Database last updated on February 28, 2009

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