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

Catalog Number 830041BL

Device Problem Migration (4003)

Patient Problems Autoimmune Reaction (1733); Erosion (1750); Fatigue (1849); Incontinence (1928); Pain (1994); Swelling (2091); Abdominal Distention (2601)

Event Date 11/03/2006

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent a gynecological procedure on (b)(6) 2006 and the mesh was implanted.The patient is experiencing multiple symptoms including pelvic, joint, bone and muscle pain, multiple autoimmune symptoms including total hair loss, fatigue, insomnia, temperature intolerance, bloating, urine flow problems, incontinence, skin problems, bowel problems, swelling, memory loss brain fog, light sensitivity, food intolerance and organ damage.Scans and examinations reveal the mesh is causing major problems including erosion.The mesh is still implanted and the patient is awaiting removal.

• 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: 8858457
• MDR Text Key: 153206063
• Report Number: 2210968-2019-85106
• 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
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2019
• 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
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention