MAUDE Adverse Event Report: ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTRL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Uterine Perforation (2121); Obstruction/Occlusion (2422); Ambulation Difficulties (2544); Not Applicable (3189)

Event Date 10/31/2016

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 following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form.

Event Description

It was reported that the patient underwent a cervical polyp surgical removal on (b)(6) 2016 and concurrently the mesh was implanted for urinary stress incontinence.As reported by patient, she experienced a bladder perforation which left her unable to void and catheter dependent.The patient reported that the mesh obstructed the urine flow.It was also reported that the patient experienced painful uti infections, chronic foreign body response, inflammation, psoriasis, hair loss, fungi toenails and painful throbbing gums.The patient stated that the mesh shred her insides.The patient was prescribed a pain medication, lyrica and endone.The patient is still in pain, some days in chronic pain, having on-going anxiety, stress and ptsd.The patient is fully incontinent and slow.18 months ago, the patient underwent a mesh removal.Even she is free of mesh but some days experiencing pain and unable to walk without a stick.Additional information has been requested.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• 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: 8505672
• MDR Text Key: 141654112
• Report Number: 2210968-2019-80273
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: TVTRL
• Device Lot Number: 3884276
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention