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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL MERSILENE POLYESTER FIBER MESH MESH, SURGICAL

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JOHNSON & JOHNSON INTERNATIONAL MERSILENE POLYESTER FIBER MESH MESH, SURGICAL Back to Search Results
Catalog Number MERSMESHUNK
Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Unspecified Infection (1930); 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 information 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) 2009 and mesh was implanted. It was reported that she experienced undisclosed injuries. It was reported that the patient underwent a revision surgery on an unknown date. No additional information was provided.

 
Manufacturer Narrative

Date sent to the fda: 9/7/2016.

 
Manufacturer Narrative

It was reported that following insertion the patient experienced erosion, vaginal discharges and infection. It was reported that the patient underwent laparoscopic removal of mersilene sling on (b)(6) 2011 by (b)(6). It was reported that the patient underwent removal of remaining fragments of merseline mesh on (b)(6) 2011 by (b)(6).

 
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Brand NameMERSILENE POLYESTER FIBER MESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
JOHNSON & JOHNSON INTERNATIONAL
leonardo da vincilaan 15
diegem NJ 1831
BE 1831
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt NJ D-228 51
GM D-22851
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5717603
MDR Text Key47140385
Report Number2210968-2016-09700
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
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 10/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMERSMESHUNK
Device LOT NumberUNKNOWN
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 Received10/06/2016
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: 06/10/2016 Patient Sequence Number: 1
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