MAUDE Adverse Event Report: COLOPLAST TOT BLADDER SLING

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Autoimmune Disorder (1732); Hair Loss (1877); Laceration(s) (1946); Neuropathy (1983); Pain (1994); Septic Shock (2068); Urinary Tract Infection (2120); Ambulation Difficulties (2544); Intermenstrual Bleeding (2665)

Event Type  Injury  

Event Description

Bladder sling caused vaginal pain, bleeding, painful intercourse and chronic uti's.My husband suffered a penile laceration during intercourse.I have neuropathy in my left foot and sciatica type pain down left leg.I have difficulty standing, sitting and walking.I spent 4 days in icu due to septic shock from a uti.I have developed several autoimmune diseases and have lost over half of my hair since the coloplast tot sling was implanted on (b)(6) 2010.

• Brand Name: TOT BLADDER SLING
• Type of Device: TOT BLADDER SLING
• Manufacturer (Section D): COLOPLAST
• MDR Report Key: 5725461
• MDR Text Key: 47499762
• Report Number: MW5062842
• 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: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 140