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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MTS PWLD EXCLUDES FLOOR PLATE; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO MTS PWLD EXCLUDES FLOOR PLATE; STRETCHER, WHEELED Back to Search Results
Model Number 639005550003
Medical Device Problem Code Sharp Edges (4013)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/15/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the device had accessible sharp metal edges.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Additional Manufacturer Narrative
This follow up report is to reflect the correction of results code to fracture problem.
 
Event or Problem Description
It was reported the device had accessible sharp metal edges.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
MTS PWLD EXCLUDES FLOOR PLATE
Common Device Name
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key11287024
Report Number0001831750-2021-00523
Device Sequence Number19693158
Product Code FPO
UDI-Device Identifier07613327504453
UDI-Public07613327504453
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K113598
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/08/2021
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
Operator of Device No Information
Device Model Number639005550003
Device Catalogue Number639005550003
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 01/15/2021
Supplement Date Received by Manufacturer01/15/2021
Initial Report FDA Received Date02/05/2021
Supplement Report FDA Received Date02/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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