MAUDE Adverse Event Report: ETHICON/ JOHSON & JOHNSON GYNECARE TVT VAGINAL OBTURATOR

Model Number 19642

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 01/11/2007

Event Type  Injury  

Event Description

In (b)(6) 2007, i had johnson & johnson sling gynecare tvt implanted for stress urinary incontinence.Upon waking from surgery, i was in severe pain in boh my hips.I went home with a catheter and on the second day post op.Began having vaginal muscle pain.I underwent many rounds of pelvic floor therapy.I experienced dyspareunia, hip pain, and decline of quality of life.

• Brand Name: GYNECARE TVT VAGINAL OBTURATOR
• Type of Device: GYNECARE TVT VAGINAL OBTURATOR
• Manufacturer (Section D): ETHICON/ JOHSON & JOHNSON
• MDR Report Key: 6025434
• MDR Text Key: 57460594
• Report Number: MW5065359
• Device Sequence Number: 1
• Product Code: OTN
• 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: 10/10/2016

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: 19642
• Device Catalogue Number: 810081
• Device Lot Number: 2898069
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DIGESTION SUPPORT; FISH OIL; HERBAL ARTHRITIS; MULTI VITAMIN; ZOCOR
• Patient Outcome(s): Other; Disability
• Patient Age: 51 YR
• Patient Weight: 66