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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; PEDIATRIC OPEN HOSPITAL BED
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STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; PEDIATRIC OPEN HOSPITAL BED Back to Search Results
Catalog Number FL19H
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem Laceration(s) (1946)
Event Date 12/10/2013
Event Type  malfunction  
Event Description
It was reported via repair work order that the cub crip had a sharp edge exposed, resulting in a caregiver cutting their hand.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
A visual and functional inspection was allegedly performed by a biomed representative at the user facility.It was reported that a house keeper cut their finger due to a sharp edge near the hinges of the foot skin during cleaning.It was confirmed that the alleged cut did not require medical intervention.It was reported by the user facility biomed representative that the sharp edges are occurring due to the procedure of the cleaning staff at the account.When cleaning the units, the foot section is raised so that the foot section is over the head section.When the cleaning staff puts pressure on the hinge point, the foot section goes past the normal stopping point, causing damage to occur.The customer will be replacing the foot sections at their own discretion.
 
Event Description
It was reported via repair work order that the cub crip had a sharp edge exposed, resulting in a caregiver cutting their hand.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
CUB PEDIATRIC CRIB- HYD BASE
Type of Device
PEDIATRIC OPEN HOSPITAL BED
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
anthony noora
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3559109
MDR Text Key4433134
Report Number0001831750-2014-00224
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 12/11/2013
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 Other
Device Catalogue NumberFL19H
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/11/2013
Initial Date FDA Received01/07/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/25/2014
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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