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

MAUDE Adverse Event Report: COLOPLAST A/S SABRE SLING 1.0X3.0CM URETHRAL SLING

  • 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 A/S SABRE SLING 1.0X3.0CM URETHRAL SLING Back to Search Results
Model Number 5194901000
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Hematuria (2558); Dysuria (2684)
Event Date 01/19/2007
Event Type  Injury  
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
As reported to coloplast, though not verified, the patient's legal representative stated unmeasured erosion of sabre through the left anterior vaginal wall, urinary frequency, dysuria, bladder pain, recurrent sui with recurrent excoriation to perineal/vaginal area, urinary urgency, suprapubic tenderness, hematuria - cystocele, lump on right labia, nocturia, groin pain, recurrent uti's.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABRE SLING 1.0X3.0CM
Type of DeviceURETHRAL SLING
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, da 3050
DA 3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6080421
MDR Text Key59219988
Report Number2125050-2016-00349
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial
Report Date 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5194901000
Device Catalogue Number5194901000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/04/2016 Patient Sequence Number: 1
-
-