MAUDE Adverse Event Report: ETHICON INC. TVT DEVICE (3 PK) LCM ::; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 830041BL

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2017 and mesh was implanted.Three-months post-op, the mesh was visible and patient experienced failure closure.The patient underwent another surgical procedure and is reported to be recovering.No additional information was provided.

• Brand Name: TVT DEVICE (3 PK) LCM ::
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 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 08876-0151 ; 9082182792
• MDR Report Key: 7143689
• MDR Text Key: 95662877
• Report Number: 2210968-2017-71939
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2017

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 Catalogue Number: 830041BL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention