• 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. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT 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. 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 Seroma (2069); Post Operative Wound Infection (2446); Blood Loss (2597); Not Applicable (3189)
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. Attempts are being made to obtain the following information. If further details are received at the later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: int surg 2015;100:1040¿1047; doi: 10. 9738/intsurg-d-14-00304. 1. (b)(4).

 
Event Description

It was reported via journal article "title : the effect of the use of synthetic mesh soaked in antibiotic solution on the rate of graft infection in ventral hernias: a prospective randomized study" author : hakan yabanog¿ lu, i¿lker murat arer, kenan c¸ aliskan citation: int surg 2015;100:1040¿1047; doi: 10. 9738/intsurg-d-14-00304. 1. This study aimed to investigate the effect of the use of synthetic mesh soaked in vancomycin solution on the rate of graft infection. Between nov2013 and oct2014, 52 patients underwent open ventral hernia repair with synthetic mesh and were randomized into two groups: group 1 (n=26) ¿ control group and group 2 (n=26) ¿ synthetic mesh was soaked in a vancomycin solution before it was implanted. On both groups, prolene mesh was used. After the procedure, complications included seroma formation (n=8); bleeding (n=1) which was operated on early and hemostasis was achieved; ssi 2 wound infection (n=9) treated with wound-site revision (n=7), valve anti-cheat therapy (n=3), removal of synthetic mesh (n=2) and partial removal (n=1); and ssi 1 wound infection (n=3) treated with wound care and oral antibiotics. Use of synthetic mesh soaked in vancomycin solution had no beneficial effect on wound-site infection. This may have been because the majority of proliferated bacteria were different from the members of normal skin flora, and thus vancomycin had limited effect.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
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
road 183, km. 8.3
san lorenzo PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7935236
MDR Text Key122803448
Report Number2210968-2018-76321
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeTU
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 09/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
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

Patient TREATMENT DATA
Date Received: 10/04/2018 Patient Sequence Number: 1
-
-