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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 AA6116
Device Problem Failure to Deflate (4060)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
According to the available information the balloon was unable to be deflated.
 
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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 Key19082267
MDR Text Key339857657
Report Number9610711-2024-00079
Device Sequence Number1
Product Code EZL
UDI-Device Identifier03600040127490
UDI-Public3600040127490
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 04/10/2024
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 Catalogue NumberAA6116
Device Lot Number9404783_AA61161002
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/10/2024
Date Device Manufactured10/02/2023
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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