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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; STRETCHER, WHEELED

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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; STRETCHER, WHEELED Back to Search Results
Catalog Number UNK_MED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 01/15/2019
Event Type  Injury  
Event Description
It was alleged that a transport employee incurred a hand/wrist injury while using the device at work.
 
Manufacturer Narrative
It was originally reported that a user incurred a hand/wrist injury, however upon completion of the event investigation it was identified to be a foot injury.As a result of this reported event, a stryker quality assurance engineer spoke with a representative at the user facility who stated that 2 transporters were moving a stretcher with a patient when the transporter at the head end stopped moving and the transporter at the foot end continued to push the stretcher, which resulted in the 1 transporter running over the foot of the other transporter.The injured transporter had an x-ray which showed a hairline fracture to their toe.The transporter did not need a cast but did require medical treatment and was not able to work for a few days.The user facility did not know the exact model or serial number of the unit, but stated that it was a prime stretcher and that there were no defects with the stretcher.
 
Event Description
It was alleged that a transport employee incurred a foot injury while using the device at work.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key8337525
MDR Text Key136108577
Report Number0001831750-2019-00268
Device Sequence Number1
Product Code FPO
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 03/11/2019
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 NumberUNK_MED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/15/2019
Initial Date FDA Received02/13/2019
Supplement Dates Manufacturer Received01/15/2019
Supplement Dates FDA Received03/11/2019
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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