MAUDE Adverse Event Report: ETHICON INC. ARTISYN Y-SHAPED MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	XCARTY
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure the diagnosis and indication for the initial surgical procedure? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? other relevant patient history/concomitant medications please provide details of the re-operation.What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status?.
Event or Problem Description
It was reported that the patient underwent an uncomplicated sacrocolpopexy surgery in (b)(6) 2016 and the mesh was implanted.At the 3 months post-op, a little mesh exposure was found on the right side of the vaginal top.It was also reported that first the patient was waiting with treatment, but when patient came for control in (b)(6) 2018, the patient wanted to have the mesh exposure removed.The mesh exposure removal was performed on (b)(6) 2018.Additional information has been requested.

• 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 0151
• MDR Report Key: 7941082
• Report Number: 2210968-2018-76359
• Device Sequence Number: 14016865
• Product Code: OTO
• UDI-Device Identifier: 10705031202795
• UDI-Public: 10705031202795
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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 Date: 10/31/2017
• Device Catalogue Number: XCARTY
• Device Lot Number: JM8GTCC0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention