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U.S. Department of Health and Human Services

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

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STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- FIXED BASE; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Catalog Number FL19F
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Head Injury (1879); Injury (2348)
Event Date 10/11/2018
Event Type  malfunction  
Event Description
It was reported that a young patient fell out of a crib and sustained injuries to the face and head.The patient underwent a ct following the alleged incident.
 
Manufacturer Narrative
The customer could not identify which specific unit this event had occurred on.The child had fallen through the front gate and sustained a cut to his lip.A ct scan was performed for precautionary measures.The injury was treated simply with ice and no medical intervention was necessary.The customer had confirmed that this was a user error and that they provided retraining to the staff.
 
Event Description
It was reported that a young patient fell out of a crib and sustained injuries to the face and head.
 
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Brand Name
CUB PEDIATRIC CRIB- FIXED 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 Key8053429
MDR Text Key126632355
Report Number0001831750-2018-01426
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 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue NumberFL19F
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/11/2018
Initial Date FDA Received11/08/2018
Supplement Dates Manufacturer Received10/11/2018
Supplement Dates FDA Received01/07/2019
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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