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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure to Anastomose (1028); Abscess (1690); Fistula (1862); Post Operative Wound Infection (2446)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative

(b)(4). This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: european journal of surgical oncology 47 (2021) e32ee62.

 
Event Description

Title: use of synthetic mesh is safe in stoma reversal. The aim of this retrospective study was to asses the safety and feasibility of synthetic meshes during closure. From feb 2018 to feb 2020, 24 patients, 19 of them were ileostomy closures while 5 were colostomies, underwent reversal of stoma and were placed an on-lay prolene mesh during the closure. 2 patients developed anastomotic leak and enterocutaneous fistula. Both were treated conservatively by opening up the wound and dressings. 7 patients developed ssi and 1 of them developed abdominal wall abscess. None of the patients developed mesh infection or needed mesh removal. Use of synthetic mesh is safe during stoma closure. The frequency of ssi increases after the placement of mesh but once the mesh gets incorporated, does not need to be removed. We advise placement of synthetic mesh during the reversal to prevent incisional hernias.

 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11711065
MDR Text Key247713117
Report Number2210968-2021-03667
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodePK
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 03/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
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?
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/22/2021 Patient Sequence Number: 1
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