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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME BIG WHEEL STRETCHER 30"; STRETCHER, WHEELED

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STRYKER MEDICAL-KALAMAZOO PRIME BIG WHEEL STRETCHER 30"; STRETCHER, WHEELED Back to Search Results
Catalog Number 1115000030
Device Problem Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2024
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.5 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 6 malfunction events, where it was reported the devices experienced accessible sharp metal edges.There was no patient involvement.
 
Manufacturer Narrative
The device pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Section h codes have been updated to reflect this.
 
Event Description
This report summarizes 6 malfunction events, where it was reported the devices experienced accessible sharp metal edges.There was no patient involvement.
 
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Brand Name
PRIME BIG WHEEL STRETCHER 30"
Type of Device
STRETCHER, WHEELED
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
melissa simon
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key19155779
MDR Text Key341422592
Report Number0001831750-2024-00452
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327278330
UDI-Public07613327278330
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported6
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/01/2024
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 Number1115000030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/22/2024
Supplement Dates Manufacturer Received04/01/2024
Supplement Dates FDA Received07/01/2024
Was Device Evaluated by Manufacturer? Yes
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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