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

Catalog Number 830041BL

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

Patient Problems Autoimmune Reaction (1733); Cyst(s) (1800); Incontinence (1928); Pain (1994); Swelling (2091); No Code Available (3191)

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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a gynecological procedure on an unknown date and mesh was implanted.The patient reported experiencing fibromyalgia, abdominal pain, bladder problems, chronic back leg groin feet and stomach pain, autoimmune conditions, bowel and bladder incontinence, swollen abdomen and cyst fallopian tubes.No additional information is available.

• 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
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7506432
• MDR Text Key: 108007120
• Report Number: 2210968-2018-72725
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 04/11/2018

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 Expiration Date: 07/31/2012
• Device Catalogue Number: 830041BL
• Device Lot Number: 3342420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/11/2018
• Date Device Manufactured: 07/31/2009
• 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