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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL OVERGUIDE 5/15ML CH18; SILICONE FOLEY CATHETER
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COLOPLAST A/S FOLYSIL OVERGUIDE 5/15ML CH18; SILICONE FOLEY CATHETER Back to Search Results
Model Number AA64181002
Medical Device Problem Code Burst Container or Vessel (1074)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
 
Event or Problem Description
According to the available information, when refilling the balloon, the balloon bursts.No harm to user.
 
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Brand Name
FOLYSIL OVERGUIDE 5/15ML CH18
Common Device Name
SILICONE FOLEY CATHETER
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
MDR Report Key8371536
Report Number9610711-2019-00010
Device Sequence Number16408453
Product Code EZL
UDI-Device Identifier03600040130087
UDI-Public03600040130087
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K013174
Number of Events Summarized1
Summary Report (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) 02/20/2019
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 NumberAA64181002
Device Catalogue NumberAA6418
Device Lot Number6448375
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/30/2019
Initial Report FDA Received Date02/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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