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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
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COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL Back to Search Results
Catalog Number AA6106
Device Problem No Flow (2991)
Patient Problem Urinary Retention (2119)
Event Date 01/29/2024
Event Type  malfunction  
Event Description
According to the available information the balloon was checked before the catheter was inserted.The nurse realized that the urinary catheter was leaking during the first treatments of the day.The nursing team concluded that there is a very strong suspicion that the balloon is punctured and non-porous.The catheter was removed immediately.A new urinary catheter had to be reinserted.
 
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Brand Name
FOLYSIL SILICONE CATHETER
Type of Device
INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
Manufacturer (Section D)
COLOPLAST A/S
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA  3050
Manufacturer (Section G)
CMF-SARLAT
9 avenue edmond rostand
sarlat-la-caneda
FR  
Manufacturer Contact
usbes brian schmidt
1601 west river road n
minneapolis, MN 55411
MDR Report Key18791333
MDR Text Key336363144
Report Number9610711-2024-00045
Device Sequence Number1
Product Code EZL
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 02/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAA6106
Device Lot Number9453607_AA61061002
Is the Reporter a Health Professional? Yes
Date Device Manufactured11/08/2023
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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