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

Catalog Number 810081L

Device Problem Migration (4003)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Not Applicable (3189)

Event Type  Injury  

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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure? name of initial surgical procedure in 2009? the diagnosis and indication for the initial surgical procedure? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? other relevant patient history/concomitant medications? if applicable, will product be returned, return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? note: the first event of exposed mesh and overlaying calculus on (b)(6) 2015 along with mesh and stone removal was reported via medwatch 2210968-2018-77305.

Event Description

It was reported that the patient underwent a sling procedure in 2009 and the mesh was implanted.On (b)(6) 2015 the mesh was found to be exposed in vagina with overlaying calculus.The exposed mesh and stone was removed.This occurred on a second occasion, most recent in 2018.Exposed mesh and stone removed surgically.No evidence of urethral mesh erosion.Additional information has been requested.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8100348
• MDR Text Key: 128245105
• Report Number: 2210968-2018-77306
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2009
• Device Catalogue Number: 810081L
• Device Lot Number: 3227766
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention