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

Model Number	ARTY
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Calcium Deposits/Calcification (1758); Micturition Urgency (1871); Incontinence (1928); Burning Sensation (2146)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure? were any concurrent devices implanted? were there any intra-operative complications? when was the mesh exposure first noted by a physician? please provide the mesh exposure site/location, symptoms and diagnostic confirmation.Describe any medical/surgical intervention for the exposure including dates and findings.Was the exposed mesh excised? were any deficiencies or anomalies noted with mesh device? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? will product be returned for analysis? 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.For the finished device batch, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an urological procedure on an unknown date in 2015 and mesh was implanted.On (b)(6) 2022, a large urinary bladder stone 4 x4 cm was partially removed by a private urologist.Part of the mesh and possible bladder stone left were noted.The patient was referred to the hospital for planning an operation to remove mesh and bladder stone.The patient has had a burning sensation below for a long time, but does not have symptoms of urinary tract infection now.No pain, but feeling of stretch on the left side.Uses vagifem every 2 days.Urinary incontinence present before the operation has possible worsening, both urgency and stress urinary incontinence and unexpected incontinence episodes.Cystoscopic removal of mesh from the bladder with a urologist was mentioned.Additional information has been requested.

• Brand Name: ARTISYN Y-SHAPED MESH
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16724263
• Report Number: 2210968-2023-02634
• Device Sequence Number: 18171857
• Product Code: OTO
• UDI-Device Identifier: 10705031218475
• UDI-Public: 10705031218475
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K113205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 12/01/2016
• Device Model Number: ARTY
• Device Catalogue Number: ARTY
• Device Lot Number: JA8BDMB0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown