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	Inflammation (1932); Pain (1994)
Date of Event	07/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.The patient demographic info: weight, bmi at the time of index procedure.The diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? were any concomitant procedures performed? onset date/time of the pain from surgery? is there any specific activity that precipitated the pain or eased the pain? was medical intervention given for the pain management or inflammation? results? if reoperation was performed, please provide date and surgical findings was the device removed? if so, please date and 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 a patient underwent a surgery of laparoscopic total hysterectomy, bilateral adnexectomy, vaginal vaginosacral suspension, anterior and posterior vaginal wall repair on (b)(6) 2021 and the mesh was implanted.It was reported that the patient suffered from abdominal pain and lumbosacral referred pain after using the product.It was also reported that the patient experienced post-op inflammation.It was also reported that the patient was given symptomatic management and regular reexamination.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/20/2021.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, 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.The following information was requested, but unavailable: the patient demographic info: weight, bmi at the time of index procedure.The diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? were any concomitant procedures performed? onset date/time of the pain from surgery? is there any specific activity that precipitated the pain or eased the pain? was medical intervention given for the pain management or inflammation? results? if reoperation was performed, please provide date and surgical findings was the device removed? if so, please date and 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?.

• 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; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12605443
• Report Number: 2210968-2021-09468
• Device Sequence Number: 19839512
• Product Code: OTO
• UDI-Device Identifier: 10705031218475
• UDI-Public: 10705031218475
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 10/31/2022
• Device Model Number: ARTY
• Device Catalogue Number: ARTY
• Device Lot Number: QMBCKKD0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 12/24/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female