MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MTS PWLD EXCLUDES FLOOR PLATE; STRETCHER, WHEELED

Model Number	639005550003
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two employees experienced pinched fingers while trying to unload a cot from the powerload.Information about the severity of the injuries has not been provided.
Additional Manufacturer Narrative
The b5 summary and section h codes were updated to more accurately reflect the completed investigation.
Event or Problem Description
It was reported that two employees experienced pinched fingers while having difficulty trying to unload a cot from the powerload.No serious injury was alleged to have occurred as a result of the pinching.
Additional Manufacturer Narrative
The b1, b5 summary, and section h codes have been updated to reflect the completed investigation.
Event or Problem Description
It was reported that two employees experienced pinched fingers while trying to unload a cot from the powerload.No serious injury was alleged to have occurred as a result of the pinching.

• 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
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12520728
• Report Number: 0001831750-2021-01326
• Device Sequence Number: 4014178
• Product Code: FPO
• UDI-Device Identifier: 07613327504453
• UDI-Public: 07613327504453
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K113598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2021

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
• Device Model Number: 639005550003
• Device Catalogue Number: 639005550003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 08/27/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 12/07/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown