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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/01/2019
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. No additional information is available. If further details are received at a later date a supplemental medwatch will be sent.

 
Event Description

It was reported in a journal article with title: prophylactic onlay reinforcement with absorbable mesh (polyglactin)is associated with less early wound complications after kidneytransplantation: a preliminary study. Incidence of wound complications after kidney transplantation (ktx) is still considerable. Here, wereport the impact of prophylactic absorbable polyglactin (vicryl; ethicon) mesh reinforcement on the incidence of short-termpost-ktx wound complications. Sixty-nine patients were analyzed; 23 with and 46 without preventiveonlay mesh reinforcement. Reported complications included surgical site infections (ssi) (n=23), wound complications (n=30). In conclusion we conclude that mesh reinforcement does not increase the risk of ssi and overall wound complications. Long-term outcomes have to be evaluated in a randomized trial setting.

 
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Brand NameVICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12022128
MDR Text Key264369260
Report Number2210968-2021-05658
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK810428
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 05/18/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/17/2021
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 Received05/18/2021
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

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