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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL SDN BHD FOLEY CATHETER; CATHETER, RETENTION TYEPE, BALLOON
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UNOMEDICAL SDN BHD FOLEY CATHETER; CATHETER, RETENTION TYEPE, BALLOON Back to Search Results
Model Number MM51161210P
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2014
Event Type  malfunction  
Event Description
Product packaging cannot be opened in a sterile way, packaging tears.
 
Manufacturer Narrative
Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.No additional pt or event details have been provided to date.Should additional info become available, a follow-up report will be submitted.
 
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Brand Name
FOLEY CATHETER
Type of Device
CATHETER, RETENTION TYEPE, BALLOON
Manufacturer (Section D)
UNOMEDICAL SDN BHD
bakar arang industrial estate
sungai petani, kedah 08000
MY  08000
Manufacturer Contact
matthew walenciak
211 american avenue
interim associated director
greensboro, NC 27409
9083779293
MDR Report Key4347234
MDR Text Key15127133
Report Number9611710-2014-00389
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K954752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/18/2014
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 NumberMM51161210P
Device Lot Number409062R001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/18/2014
Initial Date FDA Received12/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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