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

Catalog Number 810081

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was stated in the description that the mesh may have to be taken out and the procedure possibly redone, was the mesh taken out and/or the procedure redone? how is the patient today? was any intervention needed or treatment rendered? did the mesh have any holes or tears in it? it was reported that "dr.Mentioned that this is not the first time seeing loose/disintegrated prolene mesh out from the sling".Please provide a product complaint number if previous event was already reported.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on unknown date and the mesh was implanted.It was reported when the mesh was taken out from sterile pack, a loose/disintegrated piece of mesh was observed and there was a concern if this might lose the integrity of the mesh.The implant has been implanted in the patient.The patient is under monitoring and observation if the mesh needs to be taken out.Additional information has been requested.

Manufacturer Narrative

Additional summary: one empty opened blister with the lid identified with lot number 3932675 and product code 810081 received for evaluation.The mesh was not returned for evaluation.The device (mesh) was removed from the blister.The blister received was manipulated: the blister was opened.Particles of blue mesh are visible in the blister.However, this defect is not linked to a manufacturing issue, these particles are due to the manipulation and cutting method of mesh (manual cutting for product code 810081).Additional information was requested, and the following was obtained: it was stated in the description that the mesh may have to be taken out and the procedure possibly redone, was the mesh taken out and/or the procedure redone? mesh was not taken out.How is the patient today? waiting to come back for post op review.Was any intervention needed or treatment rendered? no.Did the mesh have any holes or tears in it? no.

• 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: 8629212
• MDR Text Key: 145686668
• Report Number: 2210968-2019-81609
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 810081
• Device Lot Number: 3932675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 05/31/2019
• Patient Sequence Number: 1