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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ELECTRIC MED/SURG BED; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO ELECTRIC MED/SURG BED; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number FL23SE
Device Problem Peeled/Delaminated (1454)
Patient Problem Injury (2348)
Event Date 02/21/2014
Event Type  malfunction  
Event Description
It was reported that the chrome was peeling from the head right side rail which allegedly may have lead to an injury.The extent of involvement and whether there was any clinically relevant delay in treatment is unknown.
 
Event Description
It was reported that the chrome was peeling from the head right side rail which allegedly may have lead to an injury.The extent of involvement and whether there was any clinically relevant delay in treatment is unknown.
 
Manufacturer Narrative
Follow-up submitted with evaluation results provided by customer which identified that head right siderail chrome was peeling with no exposed sharp edges.Customer alleged that an injury was sustained due to the damage; however, no additional details could be provided concerning the alleged injury.(b)(4).
 
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Brand Name
ELECTRIC MED/SURG BED
Type of Device
BED, AC-POWERED ADJUSTABLE 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
pravin betala
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3691274
MDR Text Key4291626
Report Number0001831750-2014-02486
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberFL23SE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/21/2014
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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