MAUDE Adverse Event Report: COLOPLAST CORP. URETHRAL SLING

Device Problem Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Therapeutic Response, Decreased (2271)

Event Date 09/23/2014

Event Type  Injury  

Event Description

Pubovaginal sling put in, complications ever since.I had urethral and incision sling complication with these 2 surgeries including hydro/vicodin was given to me at hospital, was noted on gown, wrist and in chart not to give because allergic to meds.On (b)(6) 2014, uti , bleeding, infections, blood clots, er x 3, couldn't urinate, bladder pain, abdominal pain.Surgery went wrong; pubovaginal sling, indwelling cath.Incontinence on and off.Self cath after surgery; cath was out because couldn't urinate.Had to go for another surgery on (b)(6) 2014.Dr says maybe sling is too tight.Urethral and incision sling loosened and cut/removed.Ab test in e.R.Urine test for uti.Scope done of abdomen/urethra, bladder and vagina to check for sling.Allergic to it reaction written- noted in chart on gown wrist given by nurses prescribed by dr.And sling treated for incontinence.See scanned pages.

Event Description

Add'l info received from reporter on (b)(4) 2015: another urology doctor says bladder damage.Bladder destroyed from all these surgery implants.Still have swelling around urethral as it healed this way from bladder surgery.I believe and doctor thinks sling was lost in bladder of scar tissues.Two and three opinion did mention this.Still have chest pain.Right side rib pain.See scanned pages.

• Brand Name: URETHRAL SLING
• Type of Device: SLING
• Manufacturer (Section D): COLOPLAST CORP.
• MDR Report Key: 4442576
• MDR Text Key: 5380784
• Report Number: MW5040311
• Device Sequence Number: 2
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2015
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2015
• Patient Sequence Number: 1
• Treatment: ANTIBIOTIC; SELF CATH; IBUPROFEN; TYLENOL
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 54