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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VICRYL* MESH UNDYED; MESH, SURGICAL, POLYMERIC
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ETHICON INC. VICRYL* MESH UNDYED; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number VKML33
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Injury (2348)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
 
Event or Problem Description
It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2014 and mesh was implanted.No additional information provided.
 
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Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key7406863
Report Number2210968-2018-71637
Device Sequence Number1094941
Product Code FTL
UDI-Device Identifier10705031056909
UDI-Public10705031056909
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K810428
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date01/31/2015
Device Catalogue NumberVKML33
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/12/2018
Initial Report FDA Received Date04/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age43 YR
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