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

Model Number TVTRL

Device Problem Migration (4003)

Patient Problems Pain (1994); Pocket Erosion (2013)

Event Date 06/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3931184 and product code tvtrl.No additional information is available.If further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2018 and the mesh was implanted.It was reported that the patient experienced unbearable pain in the vagina and in the right groin that presented after sexual intercourse in (b)(6) 2018.It was reported that after being in the emergency room of the hospital where the patient had been operated on and frequented several times, the urologist detected a vaginal extrusion of the urine strip of about 1.5 cm.No additional information was 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: 12215026
• MDR Text Key: 264050099
• Report Number: 2210968-2021-06623
• 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: consumer,foreign,other
• 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3931184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention