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

Catalog Number 810081

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported the patient underwent an unknown gynecological procedure on (b)(6) 2018 and the mesh was implanted.During the procedure, when the sterile pack was opened, the mesh appeared torn.Another like product was used to complete the procedure.There were no patient consequences reported.

Manufacturer Narrative

Date sent to the fda: 01/25/2019.Additional summary: received for evaluation one gynecare tvt obturator device (2 helical passers + mesh).The device received was manipulated: the mesh of gynecare tvt obturator device is stretched and torn.Organic substances are visible on the device.The defect seen during the product evaluation is aligned with the defect described in the event description (torn mesh).The manufacturing process could not create this defect.No further investigation will be conducted on this complaint due to external cause.

• Brand Name: GYNECARE TVT OBTURATOR
• 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: 8183162
• MDR Text Key: 130987444
• Report Number: 2210968-2018-77917
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 810081
• Device Lot Number: 3931300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Date Manufacturer Received: 01/21/2019
• Patient Sequence Number: 1