Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON
  • 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 FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number AA61101002
Device Problem Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2020
Event Type  malfunction  
Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
 
Event Description
According to the available information, before insertion, an inflation test was done with no problem.After a few hours indwelling, the catheter fell off.A balloon burst was found.
 
Manufacturer Narrative
H3: after decontamination of the returned device, the balloon was inflated and bubbles were observed.The complaint was confirmed.Possible root cause was weakness in an area of the balloon's silicone material.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FOLYSIL CATHETER
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
MDR Report Key11117273
MDR Text Key225565401
Report Number9610711-2021-00001
Device Sequence Number1
Product Code EZL
UDI-Device Identifier03600040127100
UDI-Public03600040127100
Combination Product (y/n)N
PMA/PMN Number
K013174
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAA61101002
Device Catalogue NumberAA6110
Device Lot Number7081712
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Date Manufacturer Received01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-