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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VICRYL MESH 3X2CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. VICRYL MESH 3X2CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number VM302
Device Problem Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. "when removing the device from the sterile bag" is the sterile bag you are referring to the primary packaging? was the primary packaging intact? where there any holes in the packaging? please confirm the product code. Attempts are being made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that a patient underwent a dental procedure on an unknown date in 2019 and the mesh was implanted. When removing the device from the sterile bag the membrane disintegrated. A replacement device was used. There were no adverse patient consequences reported.
 
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Brand NameVICRYL MESH 3X2CM
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.-GMBH
3348 pulliam st
san angelo TX 76905 4403
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8528963
MDR Text Key142519150
Report Number2210968-2019-80501
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberVM302
Device Lot NumberJA8BBZG0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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