MAUDE Adverse Event Report: JOHNSON AND JOHNSON / ETHICON INC. ETHICON GYNECARE TVT SLING; MESH, SURGICAL

Model Number 810081I

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Hair Loss (1877); Rash (2033); Urinary Tract Infection (2120); Immunodeficiency (2156)

Event Date 10/15/2016

Event Type  Injury  

Event Description

Ethicon gynecare txt sling caused sudden immune problem show up total hair loss, multiple skin rashes, uti s and lost energy immune deficiency.I've since had full removal of the sling and face third surg now total ery to re-sling bladder with my own tissue.

• Brand Name: ETHICON GYNECARE TVT SLING
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): JOHNSON AND JOHNSON / ETHICON INC.
• MDR Report Key: 7145503
• MDR Text Key: 95807347
• Report Number: MW5074209
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/21/2017

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: No Information
• Device Model Number: 810081I
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 43 YR
• Patient Weight: 68