MAUDE Adverse Event Report: ETHICON INC.; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Catalog Number TVTUNK

Device Problem Kinked (1339)

Patient Problems Nerve Damage (1979); Pain (1994); Urinary Tract Infection (2120); Blood Loss (2597); Not Applicable (3189)

Event Date 03/28/2006

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 a gynecological procedure and mesh was implanted.The patient experienced intense pain immediately following the procedure.The patient underwent partial removal in (b)(6) 2007.The pain was not as intense, but ongoing in the groin, leg and back, causing discomfort.Nerve damage was confirmed in 2015.The remaining mesh is twisted and has bunched/shrunk and now needs to be removed.The patient experienced obturator and possible genitofemoral nerve damage, difficulty with movement due to groin, leg and back pain and constant urinary tract infections with bleeding/debris.No additional information is available.

Manufacturer Narrative

Date sent to fda: 09/03/2019.

• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• 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: 6882450
• MDR Text Key: 87158076
• Report Number: 2210968-2017-70318
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TVTUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1