• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST TSLING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COLOPLAST TSLING Back to Search Results
Model Number T SLING
Device Problems Break (1069); Stretched (1601); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2014
Event Type  No Answer Provided  
Event Description
During transvaginal tape obturator procedure, sling was placed and left sheath would not release correctly.Sheath stretched and broke.Doctor removed it through suburethral incision.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TSLING
Type of Device
TSLING
Manufacturer (Section D)
COLOPLAST
minneapolis MN 55411
MDR Report Key3607599
MDR Text Key4159942
Report NumberMW5034168
Device Sequence Number1
Product Code OTN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/30/2014
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 Health Professional
Device Expiration Date05/31/2017
Device Model NumberT SLING
Device Catalogue Number519400
Device Lot Number0850
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/31/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age39 YR
-
-