MAUDE Adverse Event Report: ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTRL

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

Patient Problems Abdominal Pain (1685); Pain (1994); Urinary Tract Infection (2120)

Event Date 02/19/2024

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: please provide the patient's demographic information including gender, weight, bmi at the time of index procedure ¿ female, 191lbs, bmi=30.83 the diagnosis and indication for the index surgical procedure? ¿ stress urinary incontinence were any concomitant procedures performed? ¿ no other relevant patient history/concomitant medications? ¿ h/o previously prolapse repair.Hiv positive -receives cabenuva injection every other month for hiv.What was the initial approach for the index surgical procedure? ¿ retropubic sling with tvt exact were any concurrent devices implanted? ¿ no were there any intra-operative complications? ¿ no please describe any medical intervention given including medication name and results.¿ patient went to ed with left side pelvic and abdominal pain.Physical exam unremarkable, no abdominal pain on palpation.Urinalysis with 250 leukocytes and 34 wbcs, due to the patient's symptoms we will treat for a uti, cefuroxime sent to the patient's pharmacy (500mg oral tablet bid for 7 days.What is the physician¿s opinion as to the etiology of or contributing factors to this event? ¿ post-operative urinary tract infection what is the patient's current status? ¿ resolved.Product code and lot number? ¿ gynecare tvt.Lot: 3944725 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 sling procedure on (b)(6) 2024 and mesh was implanted.On (b)(6) 2024, the patient presented with moderate left side pelvic, abdominal pain and urinary tract infection.The physical exam was unremarkable and there was no abdominal pain on palpation.Urinalysis showed 250 leukocytes and 34 wbcs.Due to the patient's symptoms, the patient was treated for urinary tract infection with cefuroxime (500mg oral tablet bid for 7 days).As of (b)(6) 2024, the patient has recovered/resolved with sequelae.This event was reported as probably related to both the study device and study procedure.Additional information was 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 EXACT RETROPUBIC SYSTEM
• 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: 19144841
• MDR Text Key: 340612421
• Report Number: 2210968-2024-04601
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132054
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TVTRL
• Device Lot Number: 3944725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2023
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 87 KG