MAUDE Adverse Event Report: ETHICON INC. JOHNSON & JOHNSON TVT-O

Model Number 810081

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091); Depression (2361); Disability (2371); Device Embedded In Tissue or Plaque (3165)

Event Date 10/18/2011

Event Type  Injury  

Event Description

Bladder mesh implant in 2011.Since then allergies, pain, bleeding, bruising, pain in stomach, pain in my anus, my immune system low, swollen legs, pain in pelvic and cannot have sex.Six surgeries, pain management, and just lies from the doctors.Still have the mesh inside.Can't hardly work and full of depression.

• Brand Name: TVT-O
• Type of Device: TVT-O
• Manufacturer (Section D): ETHICON INC. JOHNSON & JOHNSON
• MDR Report Key: 5341339
• MDR Text Key: 35023531
• Report Number: MW5058863
• 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: 12/28/2015

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: 810081
• Device Lot Number: 3548284
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 32 YR
• Patient Weight: 68