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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 Tissue Damage (2104)
Event Date 02/20/2019
Event Type  Injury  
Manufacturer Narrative
Device could not be identified.
 
Event Description
It was reported that allegedly the user of the cot received two bulging discs and bilateral biceps tendon damage during use of the device.Further injury treatment information has not been provided.
 
Manufacturer Narrative
The device user stated that the injuries were not due to a specific incident and that it was a result of repeated action over a period of time.It was confirmed that the injuries were not a direct result of using the product.
 
Event Description
It was reported that allegedly the user of the cot received two bulging discs and bilateral biceps tendon damage.
 
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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 Key8438280
MDR Text Key139408121
Report Number0001831750-2019-00283
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 other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/27/2019
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? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/20/2019
Initial Date FDA Received03/20/2019
Supplement Dates Manufacturer Received02/20/2019
Supplement Dates FDA Received08/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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