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

Catalog Number TVTRL

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Scar Tissue (2060); Burning Sensation (2146); Fluid Discharge (2686)

Event Date 03/24/2024

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.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.Name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? 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? what symptoms did the patient experience following the index surgical procedure? onset date? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? when was the mesh exposure first noted by a physician? please provide the mesh exposure symptoms and diagnostic confirmation.Describe any medical/surgical intervention including dates and findings.Was the exposed mesh excised? were any deficiencies or anomalies noted with mesh device? can you please clarify/define "ics 4aet2s3"? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? 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.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

Event Description

It was reported that a patient underwent a laparoscopic total hysterectomy with suburethral band strip on (b)(6) 2024 and mesh was implanted.The patient experienced post-operative pre-pubic hematoma monitored as ambulatory and was also admitted for clear discharge from the suprapubic scar on the left side.Since the operation, there has been no hematuria and some slight urinary burning.Positive ecbu was treated with amoxicillin and mycosis was also treated.A cystoscan in the prone position confirmed an early vesico-cutaneous fistula on probable endo-vesical perforation of the band strip.Urethrovesical fibroscopy concluded bladder exposure of the strip.Total vaginal removal of the suburethral strip was performed by vaginal access.Period of occurrence: one week.Additional information has been requested.

• 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: 19163874
• MDR Text Key: 340827939
• Report Number: 2210968-2024-04772
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• 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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: TVTRL
• Device Lot Number: 3944711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• 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