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

Model Number 810041B

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Hematuria (2558)

Event Type  Injury  

Event Description

(b)(6) received an e-mail from the ethicon risk manager team stating the following: it was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and tvt was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.Additional information also reported that following insertion the patient experienced hematuria, voiding dysfunction, pain, erosion, extrusion, infection, urinary/bowel problems, fistulae, recurrence, bleeding, dyspareunia, neuromuscular problems and vaginal scarring.

Manufacturer Narrative

This emdr represents supplemental report # 2210968-2014-16143 for previously submitted mdr number 2210968-2014-15461, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037 beyond its revoke date, as documented under (b)(4) (ethicon¿s internal reference number).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.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.

• Brand Name: GYNECARE TVT DEVICE
• 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: 12842452
• MDR Text Key: 281136052
• Report Number: 2210968-2021-11739
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: 810041B
• Device Catalogue Number: 810041B
• Device Lot Number: 3398048
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 11/19/2021
• Date Device Manufactured: 01/20/2010
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 72 KG