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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMM1
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Inflammation (1932); Abnormal Vaginal Discharge (2123); No Code Available (3191)
Event Date 09/01/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Date sent to the fda: 06/01/2017. (b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent.

 
Event Description

It was reported that the patient underwent an open sacrocolpopexy on (b)(6) 2011 and the mesh was implanted. The procedure and recovery were uneventful six months post operatively. In (b)(6) 2016, the patient was presented with vaginal discharge as her main symptom only and a mesh erosion at the vaginal vault was discovered along with confirmed surrounding inflammation on imaging. The patient underwent a laparoscopic excision of the mesh on (b)(6) 2017 completely removing this from the vaginal vault. The procedure is uneventful with good recovery. Additional information has been requested.

 
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Brand NamePROLENE POLYPROPYLENE 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 Key6604846
MDR Text Key76430887
Report Number2210968-2017-32359
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMM1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/01/2017 Patient Sequence Number: 1
Treatment
TVT
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