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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; BED, PEDIATRIC OPEN HOSPITAL

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STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Catalog Number FL19H
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Bruise/Contusion (1754)
Event Date 01/14/2023
Event Type  malfunction  
Event Description
It was reported that one side of the crib had a handle that wasn't working great and it was sometimes difficult to turn it and move the side down.At one point the child in the crib needed their pacifier and instead of trying to pull the side down the parent stuck their arm through the bars.After they gave the child their pacifier, the arm of the parent got stuck for a minute in the bars when they tried to get out.They eventually got out but it left a bruise on their arm.No serious injury or treatment was reported for the bruised arm.
 
Manufacturer Narrative
The device user received a bruise as a result and no treatment was needed.The catalog number has been added.
 
Event Description
It was reported that one side of the crib had a handle that wasn't working great and it was sometimes difficult to turn it and move the side down.At one point the child in the crib needed their pacifier and instead of trying to pull the side down the parent stuck their arm through the bars.After they gave the child their pacifier, the arm of the parent got stuck for a minute in the bars when they tried to get out.They eventually got out but it left a bruise on their arm.No serious injury or treatment was reported for the bruised arm.
 
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Brand Name
CUB PEDIATRIC CRIB- HYD BASE
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 Key16379406
MDR Text Key309580139
Report Number0001831750-2023-00294
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 Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/29/2023
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 Catalogue NumberFL19H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/18/2023
Initial Date FDA Received02/15/2023
Supplement Dates Manufacturer Received01/18/2023
Supplement Dates FDA Received06/29/2023
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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