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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON
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COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number AA64161002
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 found a balloon "with a remanence." the balloon was inflated with 15ml of air and was 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.It created a "pleated blistering" which increased the diameter and "add reliefs" making the withdrawal difficult and painful for the patient.
 
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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 Key12661040
Report Number9610711-2021-00089
Device Sequence Number4298149
Product Code EZL
UDI-Device Identifier03600040129975
UDI-Public03600040129975
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) 10/19/2021
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 NumberAA64161002
Device Catalogue NumberAA6416
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 Date10/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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