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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
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Urinary Frequency (2275); 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) 2003 and mesh was implanted. Tvt-abbrevo was implanted on (b)(6) 2013. 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 surgical procedure and a mesh was implanted concurrently with lysis of peritoneal adhesions, operation on cul-de-sac and percutaneous cystotomy.
 
Manufacturer Narrative
Date sent to fda: 03/29/2017. Details: it was reported that following insertion the patient experienced urgency, frequency.
 
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Brand NameMERSILENE POLYESTER FIBER MESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
JOHNSON & JOHNSON INTERNATIONAL
leonardo da vincilaan 15
diegem 1831
BE 1831
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6169753
MDR Text Key62228315
Report Number2210968-2016-60104
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PRE-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 03/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received03/27/2017
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: 12/13/2016 Patient Sequence Number: 1
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