MAUDE Adverse Event Report: ETHICON, INC. GYNECARE TRANSVAGINAL SLING TVT O TAPE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number 810041B

Device Problems Device Contamination with Chemical or Other Material (2944); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475); Device Embedded In Tissue or Plaque (3165)

Event Date 03/08/2021

Event Type  Injury  

Event Description

Organ damage; recurrent uti related to tvt mesh sling resulting in revision ((b)(6) 2021).Mesh embedded in urethra muscle, neck of bladder and mesh was through the side of urethra.Uti was an esbl.Requiring 5 day hospital stay and 17 days of iv antibiotic therapy.Pelvic pain, rectal prolapse, recurrent uti for over 2 years.Mesh shrinkage.Urinary retention.There are more than 10 cultures from 2017-2021 for uti.Ultrasounds of mesh, urodynamic studies x 2 in office cystoscopes.Fda safety report id# (b)(4).

• Brand Name: GYNECARE TRANSVAGINAL SLING TVT O TAPE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 11607981
• MDR Text Key: 243798412
• Report Number: MW5100512
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/31/2021

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2018
• Device Model Number: 810041B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 47 YR
• Patient Weight: 81