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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 Problems Laceration(s) (1946); Physical Entrapment (2327)
Event Date 10/11/2014
Event Type  malfunction  
Event Description
It was reported that the hospital has had an instance where a patient has gotten their leg stuck in-between the rails on the stretcher crib.It was reported that the patient received an abrasion.
 
Manufacturer Narrative
The customer alleged that there was no malfunctions with the product and reported that the patient was unattended at the time of the alleged event.It was confirmed that the patient received an abrasion during the alleged event and that there was a training to ensure prevention of this type of event in the future.
 
Event Description
It was reported that the hospital has had an instance where a patient has gotten their leg stuck in-between the rails on the stretcher crib.It was reported that the patient received an abrasion.
 
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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 Key4867913
MDR Text Key5866079
Report Number0001831750-2015-00286
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 Other,other
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberFL19
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/01/2015
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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