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

Catalog Number 810041A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Retention (2119)

Event Date 04/01/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 323620300
• Report Number: 2210968-2023-06820
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062283
• UDI-Public: 10705031062283
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR