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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB; BED, PEDIATRIC OPEN HOSPITAL
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STRYKER MEDICAL-KALAMAZOO CUB; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Catalog Number FL19
Device Problem Sticking (1597)
Patient Problem No Patient Involvement (2645)
Event Date 04/14/2016
Event Type  malfunction  
Event Description
It was alleged by the user facility that a patients ankle became stuck between the siderail.It was not reported that the patient was adversely affected, and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
This issue was resolved for the customer by informing them that a protective pad accessory was available for sale which offers peripheral protection against the rail bars.
 
Event Description
It was alleged by the user facility that a patients ankle became stuck between the siderail.It was not reported that the patient was adversely affected, and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
CUB
Type of Device
BED, PEDIATRIC OPEN HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key5653275
MDR Text Key45142636
Report Number0001831750-2016-00163
Device Sequence Number1
Product Code FMS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberFL19
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/15/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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