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U.S. Department of Health and Human Services

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

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ETHICON INC. MERSILENE POLYESTER FIBER MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number RMS
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4) date sent to the fda: 12/20/2016. (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) 2010 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
(b)(4). It was reported that patient underwent mesh removal on (b)(6) 2011 by dr. (b)(6) at (b)(6) hospital. It was reported that following insertion the patient experienced urinary problems, recurrence and infection.
 
Manufacturer Narrative
(b)(4). It was reported that following insertion the patient experienced cystocele. In addition, a device history review has been inserted into the file.  this review indicates that there was no quality concerns associated with the manufacturing process.
 
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Brand NameMERSILENE POLYESTER FIBER MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6188888
MDR Text Key62839167
Report Number2210968-2016-60109
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,Followup
Report Date 04/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2012
Device Catalogue NumberRMS
Device Lot NumberZKE853
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 Received04/05/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/25/2007
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: 12/20/2016 Patient Sequence Number: 1
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