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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL SDN BHD SEC. 2W. PAED. 06X05; CATHETER, RETENTION TYPE, BALLOON
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UNOMEDICAL SDN BHD SEC. 2W. PAED. 06X05; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number 53160605
Device Problems Inflation Problem (1310); Occlusion Within Device (1423)
Patient Problem No Patient Involvement (2645)
Event Date 08/26/2011
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
Complainant reports "foley catheter was block." discovered during preparation.Inflation line occluded - could not inflate.
 
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Brand Name
SEC. 2W. PAED. 06X05
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
UNOMEDICAL SDN BHD
bakar arang industrial estate
sungai petani
kedah, 08000
MY  08000
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5188590
MDR Text Key29872070
Report Number9611710-2015-31063
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K770256
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
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? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number53160605
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2011
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/27/2014
Initial Date FDA Received10/29/2015
Was Device Evaluated by Manufacturer? Yes
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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