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 Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544); Foreign Body In Patient (2687)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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)- device not returned.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 (b)(6) 2019 and mesh was implanted.The patient reported experiencing severe pain immediately after in the groin, buttock and left leg with difficulty walking.The patient further reported pain in the 2 groins radiating in the front of the legs, difficulty sitting for a long time due to groin pain, stomach pain, pain during intercourse, impression of feeling the mesh in the groin and occasional internal burning sensation in the pubis.No further information is available.

• 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
• MDR Report Key: 12196343
• MDR Text Key: 262441206
• Report Number: 2210968-2021-06487
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132054
• 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

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3933644
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1