MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT-ABBREVO MINI LCM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number TVTOML

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Numbness (2415); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

Event Description

It was reported that a patient underwent a sling procedure on an unknown date and mesh was implanted.The patient reported experiencing failure of device within a few years, incontinence, constant pain, painful intercourse, pain to sit/bend/squat, numbness, pins and needles in my pelvic area and muscle spasms.The patient also reported that the mesh has eroded, migrated, and rolled.No further information is available.

• Brand Name: GYNECARE TVT-ABBREVO MINI LCM
• 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 ; GM 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12188768
• MDR Text Key: 262204676
• Report Number: 2210968-2021-06427
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062368
• UDI-Public: 10705031062368
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K100936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: TVTOML
• Device Catalogue Number: TVTOML
• Device Lot Number: 3603012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1