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

Model Number TVTRL

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

Patient Problems Calcium Deposits/Calcification (1758); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330)

Event Date 01/01/2022

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.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.(b)(4).

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2013 for stress urinary incontinence and mesh was implanted.The patient reported experiencing left hip pain, like a toothache in the hip.The patient went for many x-rays, ultrasounds, physio appointments and doctors¿ appointments, but no significant results ever came back.The patient also reported experiencing a couple of urinary tract infections and a bleed sometime after menopause.The patient had a pap smear performed that ruled out everything.The patient developed overactive bladder and had a cystoscopy in (b)(6) 2020 which ruled out erosion of tape to the bladder at the time.The patient was prescribed medication to help with the overactive bladder.An urogynaecologist had a quick chat with the patient and did a quick internal.The doctor assured the patient that the sling was in place and commented that the tape does not erode or breakdown, but sometimes there is a need to go in and snip the ends of tape that may have come away from the anchor points.The patient further experienced daily discharge from the urethra associated with foul smell, small particles of a white cotton/plastic flecks in underwear and pain/discomfort in both the urethra and vagina.The patient believes there is bacteria trapped in the mesh that will develop into an auto-immune disease from this ongoing infection.Additionally, an ultrasound noted calcification in the vagina.No further information is available.

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 non-conformances related to the malfunction 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: 16090158
• MDR Text Key: 306559807
• Report Number: 2210968-2023-00015
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3683858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2013
• 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