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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD LUBRI-SIL I.C. TEMP-SENSING FOLEY
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PRODUCTOS PARA EL CUIDADO DE LA SALUD LUBRI-SIL I.C. TEMP-SENSING FOLEY Back to Search Results
Catalog Number 119316M
Device Problem Mushroomed (2987)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that the balloon folded on itself, mushroomed.
 
Manufacturer Narrative
The sample was not returned.The lot number is unk; therefore, the device history record could not be reviewed.A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.(b)(4).
 
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Brand Name
LUBRI-SIL I.C. TEMP-SENSING FOLEY
Manufacturer (Section D)
PRODUCTOS PARA EL CUIDADO DE LA SALUD
nogales, sonora
MX 
Manufacturer (Section G)
PRODUCTOS PARA EL CUIDADO DE LA SALUD
km 7 carretera international
nogales, sonora 8562 1
MX   85621
Manufacturer Contact
kim shirah
8195 industrial blvd.
covington, GA 30014
7707846100
MDR Report Key3831859
MDR Text Key4498202
Report Number1018233-2014-00053
Device Sequence Number1
Product Code MJC
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K070582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 02/10/2014
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 Catalogue Number119316M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 02/10/2014
Initial Date FDA Received03/06/2014
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 Initial
Patient Sequence Number1
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