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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MERSILENE POLYESTER FIBER MESH MESH, SURGICAL

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ETHICON INC. MERSILENE POLYESTER FIBER MESH MESH, SURGICAL Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

 
Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 1998 and mesh was implanted. It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure. It was reported that the patient has undergone multiple surgeries and revisionary procedures. No additional information was provided.

 
Manufacturer Narrative

It was reported that the patient underwent a gynecological procedure and mesh was implanted concurrently with cystoscopy.

 
Manufacturer Narrative

Date sent to the fda: 01/05/2017. It was reported that following insertion the patient experienced recurrent urinary tract infection. It was reported that patient underwent removal of mesh on (b)(6) 1998 by dr. (b)(6). It was reported that patient underwent excision of mesh on (b)(6) 2011 by dr. (b)(6) due to recurrent stress urinary incontinence, and vaginal discharge.

 
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Brand NameMERSILENE POLYESTER FIBER MESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5851874
MDR Text Key51338132
Report Number2210968-2016-11189
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/28/2016
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/05/2016 Patient Sequence Number: 1
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