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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 RML
Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Pain (1994); Urinary Frequency (2275); Hematuria (2558); Blood Loss (2597); 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 procedure on (b)(6) 2009 and mesh was implanted. It was reported that she experienced vaginal bleeding, hematuria, and urinary frequency. No additional information was provided.
 
Manufacturer Narrative
(b)(4). It was reported that the patient underwent a gynecological surgical procedure on (b)(6)2009 and mesh was implanted. It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2014 and bs-lynx 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 provide.
 
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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
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key5986399
MDR Text Key55885130
Report Number3005075853-2016-05569
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
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
Report Date 11/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2012
Device Catalogue NumberRML
Device Lot NumberZAB900
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 Received11/14/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/11/2007
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: 09/29/2016 Patient Sequence Number: 1
Treatment
SYSTEM SLING
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