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

Catalog Number	ARTY
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Calcium Deposits/Calcification (1758); Pain (1994)
Date of Event	03/17/2018
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? other relevant patient history/concomitant medications describe any medical/surgical intervention for exposure including dates and surgical findings.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 a robot-assisted laparoscopic colposacropexy on (b)(6) 2017 and the mesh was implanted.Under the operation procedure an iatrogenic hole is formed on the bladder, and it is being sutured.After surgery, the patient had no complication at the control.One year later, the patient reports pain in the top of the vagina and pain associated with coitus.On (b)(6) 2018, cystoscopy is made showing erosion of the mesh material to the bladder accompanied by bladder stone formation.No further action has yet been taken.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: 8262224
• Report Number: 2210968-2019-78487
• Device Sequence Number: 11180638
• Product Code: OTO
• UDI-Device Identifier: 10705031218475
• UDI-Public: 10705031218475
• Combination Product (Y/N): N
• PMA/510(K) Number: K113205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2019

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: ARTY
• Device Lot Number: JM8GTCC0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention