MAUDE Adverse Event Report: ETHICON INC. TVT DEVICE WITH PROLENE TAPE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810041

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported the patient underwent a gynecological procedure on (b)(6) 2003 and tvt was implanted.It was reported that following the procedure, patient experienced pain.It was reported that patient underwent mesh removal on (b)(6) 2015 due to foreign body in bladder.It was reported that following the procedure the patient experienced erosion.It was also reported that the patient underwent a mesh removal on (b)(6) 2015 and another removal on (b)(6) 2015.No additional information was provided.

Manufacturer Narrative

This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2017-70666, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: TVT DEVICE WITH PROLENE TAPE
• 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 ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan 08869
• MDR Report Key: 12770471
• MDR Text Key: 280509083
• Report Number: 2210968-2021-10932
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2021

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: 01/15/2007
• Device Catalogue Number: 810041
• Device Lot Number: 1055850
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female