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 AA64181002
Medical Device Problem Codes Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Visual examination of the returned product revealed a balloon "with a remanence".The balloon was inflated with 15ml of air and deflated; the balloon was deformed due to over-inflation by the user.
 
Event or Problem Description
According to the available information, the balloon did not completely deflate during withdrawal, creating a "pleated blistering" which increased the diameter and "added reliefs" making withdrawal difficult and painful for the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FOLYSIL CATHETER
Common Device Name
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
MDR Report Key12704969
Report Number9610711-2021-00103
Device Sequence Number19192935
Product Code EZL
UDI-Device Identifier03600040130087
UDI-Public03600040130087
Combination Product (Y/N)N
PMA/510(K) Number
K013174
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/27/2021
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
Operator of Device Health Professional
Device Model NumberAA64181002
Device Catalogue NumberAA6418
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/27/2021
Initial Report FDA Received Date10/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-