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

Catalog Number 830041BL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Not Applicable (3189)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 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 the patient demographic info: age, weight, bmi at the time of index procedure.Date of index surgical procedure.The initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? other relevant patient history/concomitant medications.Product code and lot number.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 current status?.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and mesh was implanted.Following the procedure, the patient experienced dyspareunia and vaginal mesh exposure.On (b)(6) 2014, the patient underwent removal of vaginal mesh.The device remains in the patient.The patient presented this year with supra-pubic pain, thigh pain and recurrent stress urinary incontinence.Additional information has been requested.

• 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 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: 8176688
• MDR Text Key: 130768139
• Report Number: 2210968-2018-77882
• 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: foreign,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 830041BL
• Device Lot Number: 3665449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention