MAUDE Adverse Event Report: AMS TRANSOBURATION SLING

Lot Number 814571009

Device Problem Break (1069)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Retention (2119)

Event Date 01/31/2013

Event Type  Injury  

Event Description

Caller stated he was implanted with a mesh sling for incontinence.He stated experiencing pain, heaviness in the bladder, urinary retention and incontinence.He was told by his doctor that the mesh broke.The mesh was explanted but he was still experienced pain but the doctor refuse to see him.Consistence bladder leakage, incontinence.Medical device that was implanted eroded in the body had to be replaced with pump.This (b)(6) male that underwent a radical retropubic prostatectomy in (b)(4) 2010 beats the exact stage and gleason score preoperatively is undetermined he been followed by dr.(b)(6) and the surgery he complains of urinary incontinence wears 4 pads a day that appears to be stress urinary incontinence he is being considered for a sling procedure.This is a pt who underwent radical prostatectomy in (b)(6) 2011 for gleason's 6 adenocarcinoma.Unfortunately, the pt has been significantly incontinent ever since.He is here to discuss possible sling.The pt leaks 4 or 6 pads a day.He says he leaks while he sleeps at night and occasionally even has to get up to change his pad.He's wearing adult pull-ups.He says these are fairly wet when he changes them.The pt does void normally, as well as leak.He has no dysuria and his strength of stream is good.

• Brand Name: TRANSOBURATION SLING
• Type of Device: TRANSOBURATION SLING
• Manufacturer (Section D): AMS
• MDR Report Key: 5195421
• MDR Text Key: 30225179
• Report Number: MW5057580
• 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: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 814571009
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 100