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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER-PRO TL COT; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO POWER-PRO TL COT; STRETCHER, WHEELED Back to Search Results
Model Number 6550
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code Pain (1994)
Date of Event 05/07/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the cot would not release from the fastener and that a user was hurt while trying to release the cot.No specific injury or treatment details have been provided at this time.
 
Event or Problem Description
It was reported that the cot would not release from the fastener and that a user was hurt while trying to release the cot.No specific injury or treatment details have been provided at this time.
 
Additional Manufacturer Narrative
The section h codes have been updated to reflect the completed investigation.
 
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Brand Name
POWER-PRO TL COT
Common Device Name
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key11871893
Report Number0001831750-2021-00915
Device Sequence Number922463
Product Code FPO
UDI-Device Identifier07613327261660
UDI-Public07613327261660
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/26/2021
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? Yes
Operator of Device No Information
Device Model Number6550
Device Catalogue Number6550000000
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 05/11/2021
Supplement Date Received by Manufacturer05/11/2021
Initial Report FDA Received Date05/24/2021
Supplement Report FDA Received Date08/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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