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

Catalog Number 810041B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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.Mwr-24052019-0000439211 submitted for adverse event which occurred on (b)(6) 2013.Mwr-24052019-0000439212 submitted for adverse event which occurred on (b)(6) 2014.Report submission exceeding 30-days due to fdas exemption transitioning period.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2009 and mesh was implanted.It was reported that she experienced undisclosed injuries.It was reported that the patient underwent a revision surgery on (b)(6) 2013 and (b)(6) 2014.No additional information was provided.

Manufacturer Narrative

Stone formations.It was reported that the patient underwent a mesh revision due to calcification and stone formations.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.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8646953
• MDR Text Key: 146271196
• Report Number: 2210968-2019-81837
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

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: 09/30/2011
• Device Catalogue Number: 810041B
• Device Lot Number: 3205294
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention