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

Model Number 810081

Device Problem Migration (4003)

Patient Problems Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Urinary Tract Infection (2120); Urinary Frequency (2275); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Wcq 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) 2007 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.It was also reported that following insertion the patient experienced inflammation, infection, urinary frequency, urinary urgency, urinary tract infection, pain, erosion, extrusion, urinary/bowel problems, recurrence and bleeding.

Manufacturer Narrative

(b)(4).This emdr represents supplemental report # 2210968-2014-07031 for previously submitted mdr number 2210968-2014-08882, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037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).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 OBTURATOR
• 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 20neuchatel; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12842459
• MDR Text Key: 283324739
• Report Number: 2210968-2021-11738
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033568
• 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: 03/31/2008
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3025721
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 11/19/2021
• Date Device Manufactured: 04/19/2007
• Is the Device Single Use?: Yes
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female