• 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. VYPRO 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. VYPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number VYPROUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Seroma (2069); Urinary Retention (2119); Post Operative Wound Infection (2446)
Event Date 01/01/2010
Event Type  Injury  
Manufacturer Narrative

Product complaint #:(b)(4). (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: annals of oncology. 2010 apr; conference: 5th european multidisciplinary colorectal cancer congress,emcc. Nice france. Conference publication: (var. Pagings). 21 (1): i68. Doi: https://hostedvl106. Quosavl. Com/qb/ if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Events related to vypro mesh reported via mw # 22210968-2021-02829. Events related to prolene suture reported via mw # 22210968-2021-02830.

 
Event Description

It was reported in a journal article with title: lessons to be learned from peritoneal reconstruction for perineal hernia repair. A perineal hernia can severely disable everyday activities. Its repair is a surgical challenge andguidance by the literature is limited. The series described so far are small or encompass a long period in whicheven non-mesh techniques were used. The aim of this study was to review recent results of a mesh-based repair. Medical charts of patients with a perineal hernia repair since 2003 were reviewed. In total, 22 patients underwent repair of symptomatic perineal hernia after an abdominoperineal resection due to rectal cancer. The majority was male (73%) and the age range was from 41 to 83 years old. From 2003 until 2006 the perineal hernia was repaired using ptfe or vypro mesh (ethicon) and prolene 2. 0 sutures (ethicon). Reported complications included repairs failed (n=?) in which repeated repair using different methods (abdominal approach [n=2], suture fixation [n=2], or mesh technique [n=4]) was successful. For the total group, other complications encountered included urinary retention (n=?), wound infection (n=?), seroma (n=?), and fistula (n=?). It was concluded that the repair of perineal hernia remains challenging. In the present study,however, superior results have been shown for repositioning the hernia sac and the use of a non-absorbable meshand a stronger non-absorbable running suture.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVYPRO MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11580542
MDR Text Key246308369
Report Number2210968-2021-02829
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK002672
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 03/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberVYPROUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
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

Patient TREATMENT DATA
Date Received: 03/28/2021 Patient Sequence Number: 1
-
-