• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. MERSILENE POLYESTER FIBER MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number RML
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); 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. In addition, a device history review for in process has been inserted into the file. This review indicates that there was no quality concerns associated with the manufacturing process.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2003 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
Additional narrative: it was reported that following insertion the patient experienced urinary retention and recurrent urinary tract infection.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6166300
MDR Text Key62123220
Report Number2210968-2016-15416
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 02/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2006
Device Catalogue NumberRML
Device Lot NumberQCE127
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 Received02/28/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2001
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: 12/12/2016 Patient Sequence Number: 1
Treatment
TVT
-
-