MAUDE Adverse Event Report: ETHICON INC. TVT W/ABDOMINAL GUIDES 1 PACK; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	810041A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	04/01/2023
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.Additional information was requested and the following was obtained: surgery (b)(6) 2023: combined anteroposterior colporrhaphy sling operation for stress incontinence; cystourethroscopy.Please provide lot number: lot# 3936524.Was there any associated medical or surgical intervention to treat any of the patient consequences? if so, please clarify.Office visit ((b)(6) 2023): 4 weeks post-procedure: elevated pvr today in the office.Cathed for 125ml.Discussed importance of relaxation with emptying and avoiding straining.Return to the office in about 2-3 weeks for repeat pvr check.Office visit ((b)(6) 2023): normal pvr today.Verified via cath for only 60ml.Discussed activity restrictions in depth.What is the most current patient status? office visit ( (b)(6) 2023): 6-month post-op follow-up visit.Doing well postoperatively, healing normally.Normal pvr, no urinary retention.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
Event or Problem Description
It was reported that a patient underwent a combined anteroposterior colporrhaphy sling operation for stress incontinence on (b)(6) 2023 and mesh was implanted.In (b)(6) 2023, the patient experienced mild urinary retention.On (b)(6) 2023, 4 weeks post-procedure, elevated pvr was noted in the office.The patient was cathed for 125ml.On (b)(6) 2023, the patient presented normal pvr which was verified via cath for only 60ml.As of (b)(6) 2023, the patient is doing well postoperatively, healing normally and has normal pvr, no urinary retention.This event was reported as having a probable relationship with the study device and a causal relationship with the study procedure.Additional information has been requested.
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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• Brand Name: TVT W/ABDOMINAL GUIDES 1 PACK
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17765297
• Report Number: 2210968-2023-06820
• Device Sequence Number: 15119445
• Product Code: OTN
• UDI-Device Identifier: 10705031062283
• UDI-Public: 10705031062283
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 03/31/2023
• Device Catalogue Number: 810041A
• Device Lot Number: 3936524
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 09/24/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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 Age: 53 YR
• Patient Sex: Unknown