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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 AA64141002
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem Pain (1994)
Event Type  malfunction  
Manufacturer Narrative
Visual examination of the returned product revealed the balloon with "a remanence".The balloon was inflated with 15ml of air and was then deflated; the balloon was deformed due to over-inflation by the user.
 
Event 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 the withdrawal difficult and painful for the patient.
 
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Brand Name
FOLYSIL CATHETER
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
Manufacturer (Section G)
COLOPLAST A/S MANUFACTURING
9 avenue edmond rostand
sarlat-la-caneda 24206
FR   24206
Manufacturer Contact
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key12705241
MDR Text Key278599388
Report Number9610711-2021-00104
Device Sequence Number1
Product Code EZL
UDI-Device Identifier03600040129869
UDI-Public03600040129869
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Model NumberAA64141002
Device Catalogue NumberAA6414
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/27/2021
Initial Date FDA Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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