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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL SDN BHD 2-WAY, HARD VALVE, STANDARD TIP, 5/10CC, CH14; CATHETER, RETENTION TYPE, BALLOON
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UNOMEDICAL SDN BHD 2-WAY, HARD VALVE, STANDARD TIP, 5/10CC, CH14; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number MM51161410
Device Problem Occlusion Within Device (1423)
Patient Problem Urinary Retention (2119)
Event Date 01/24/2012
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
It is reported that, "4 times on 2 weeks, the hourly diuresis was stopped after the installation of the catheter on patients who underwent cesarean.".
 
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Brand Name
2-WAY, HARD VALVE, STANDARD TIP, 5/10CC, CH14
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
UNOMEDICAL SDN BHD
bakar arang industrial estate
sungai petani,
kedah, malaysia 08000
MY  08000
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5185139
MDR Text Key29799749
Report Number9611710-2015-31088
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K770256
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMM51161410
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/27/2014
Initial Date FDA Received10/28/2015
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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