MAUDE Adverse Event Report: BOSTON SCIENTIFIC TRANSOBTURATOR SLING

Model Number OBTRYX

Device Problems Material Fragmentation (1261); Extrusion (2934)

Patient Problems Incontinence (1928); Pain (1994); Perforation (2001); Disability (2371); Ambulation Difficulties (2544)

Event Date 03/04/2011

Event Type  Injury  

Event Description

The device did not stay where it was placed and perforated my vagina a month after it was put in.After my surgeon removed the part that was sticking, out it was okay for a couple of years.I just had surgery to have it removed as it had perforated my vagina again and was almost through my urethra.It was embedded into my muscle and was in pieces inside of me doing a lot of damaged.I had leg and nerve pain and problems walking and pain during and after sex.I was also unable to exercise or stretch or do pretty much anything.It was even painful to sleep due to the painful pulling it was doing inside.I was put on pain meds 6 months before my last surgery on (b)(6) 2014.Now in recovery phase of third suffer and having incontinence due to the trauma of the mesh.

• Brand Name: TRANSOBTURATOR SLING
• Type of Device: TRANSOBTURATOR SLING
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 3624357
• MDR Text Key: 4136266
• Report Number: MW5034341
• Device Sequence Number: 1
• Product Code: OTN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: OBTRYX
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 41 YR
• Patient Weight: 88