MAUDE Adverse Event Report: ETHICON SÀRL GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

Model Number 810081L

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 06/20/2023

Event Type  malfunction  

Event Description

Elderly female with an incomplete vaginal prolapse, worsening urge, and stress incontinence x 2 years not managed with pessary and other conservative measures.Underwent total vaginal hysterectomy, right salpingo-oophorectomy, cystoscopy with stents placement/removal, anterior colphorraphy, and midurethral sling.Complications: plastic sheath of midurethral sling dislodged and could not be retrieved from the left thigh muscle.Per surgeon, the short piece probably retracted and that the benefit of leaving it in outweighs the risk of going through the muscle.

• Brand Name: GYNECARE TVT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): ETHICON SÀRL; 1000 us highway 202 s.; raritan NJ 08869
• MDR Report Key: 17278628
• MDR Text Key: 318580611
• Report Number: 17278628
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2023,06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 810081L
• Device Catalogue Number: 810081L
• Device Lot Number: 3942374
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Female
• Patient Race: White