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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S SILIC FOLEY CATH 5/10ML /5; SILICONE FOLEY CATHETER
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COLOPLAST A/S SILIC FOLEY CATH 5/10ML /5; SILICONE FOLEY CATHETER Back to Search Results
Model Number AA61121002
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
 
Event or Problem Description
According to the available information, folysil nelaton catheter inserted to patient and it was noticed urine did not go through at all.After two hours the catheter was changed to new one which was working properly.There must be some kind of obstruction in the drainage canal.
 
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Brand Name
SILIC FOLEY CATH 5/10ML /5
Common Device Name
SILICONE FOLEY CATHETER
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, da 3050
DA  3050
MDR Report Key6291043
Report Number9610711-2017-00004
Device Sequence Number19108970
Product Code EZL
UDI-Device Identifier03600040127230
UDI-Public03600040127230
Combination Product (Y/N)N
Initial Reporter CountryFI
PMA/510(K) Number
K013174
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/31/2017
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 NumberAA61121002
Device Catalogue NumberAA61121002
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/19/2017
Initial Report FDA Received Date01/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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