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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL S.R.O. FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON
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UNOMEDICAL S.R.O. FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number MM51121410
Device Problem Delivered as Unsterile Product (1421)
Patient Problem Not Applicable (3189)
Event Date 12/17/2014
Event Type  malfunction  
Event Description
The distributor reports the outer packaging was peeled off and the inner plastic sachet containing the foley catheter was sealed and stuck to the outer sachet.
 
Manufacturer Narrative
Based on the available information, this event is deemed a reportable malfunction.The device was not reported to have been used on a patient.Should additional information become available, a follow-up report will be submitted.
 
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Brand Name
FOLEY CATHETER
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
UNOMEDICAL S.R.O.
priemyselny park 3
michalovce 07101
Manufacturer Contact
matthew walenciak, assoc director
211 american avenue
greensboro, NC 27409
9083779293
MDR Report Key4412249
MDR Text Key5376548
Report Number9611710-2015-00002
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K954752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/18/2014
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 Expiration Date05/01/2019
Device Model NumberMM51121410
Device Lot Number409380R001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/18/2014
Initial Date FDA Received01/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
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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