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

Catalog Number	639005550003
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field; no defect or malfunction was found.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the device experienced fastener no longer facilitates proper cot operations during loading/unloading.There was 1 event with patient involvement; the patient experienced muscle/tendon damage.

• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19843786
• Report Number: 0001831750-2024-00981
• Device Sequence Number: 6598385
• Product Code: FPO
• UDI-Device Identifier: 07613327504453
• UDI-Public: 07613327504453
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113598
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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
• Device Catalogue Number: 639005550003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown