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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ARTISYN Y-SHAPED MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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ETHICON INC. ARTISYN Y-SHAPED MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Model Number ARTY
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Erosion (1750)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.
 
Event or Problem Description
It was reported that the patient underwent a gynecological procedure on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent repair surgery on (b)(6) 2019 due to erosion and prolapse.No additional information was provided.
 
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Brand Name
ARTISYN Y-SHAPED MESH
Common Device Name
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10945805
Report Number2210968-2020-09573
Device Sequence Number3170581
Product Code OTO
UDI-Device Identifier10705031218475
UDI-Public10705031218475
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K113205
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Model NumberARTY
Device Catalogue NumberARTY
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/25/2020
Initial Report FDA Received Date12/04/2020
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;
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