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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UMANO MEDICAL INC FL23P MANUAL BED

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UMANO MEDICAL INC FL23P MANUAL BED Back to Search Results
Model Number FL23P
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 04/22/2019
Event Type  malfunction  
Event Description
It was reported that a manual hospital bed was found with 2 broken/damage braking casters resulting in brakes not holding.
 
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Brand NameFL23P
Type of DeviceMANUAL BED
Manufacturer (Section D)
UMANO MEDICAL INC
230 boulevard nilus-leclerc
l'islet, quebec G0R 2 C0
CA G0R 2C0
Manufacturer (Section G)
UMANO MEDICAL INC
230 boulevard nilus-leclerc
l'islet, quebec G0R 2 C0
CA G0R 2C0
Manufacturer Contact
maude thibault
230 boulevard nilus-leclerc
l'islet, quebec G0R 2-C0
CA   G0R 2C0
MDR Report Key8804669
MDR Text Key200681774
Report Number3009591865-2019-00014
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Remedial Action Repair
Type of Report Initial
Report Date 07/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFL23P
Device Catalogue NumberFL23P
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/22/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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