MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6506 MTS PWRPRO COT LOW CONFIG; STRETCHER, WHEELED

Model Number 6506

Device Problem Device Tipped Over (2589)

Patient Problem Laceration(s) (1946)

Event Date 10/13/2021

Event Type  Injury  

Event Description

It was reported that while loading a patient into the ambulance, the cot did not raise high enough causing the cot to slip off the back of the ambulance and tip over with the patient.The patient reportedly sustained a head laceration which was treated with stitches in the local er.The patient also reported that the fall aggravated an existing eye injury, however, no treatment information was available for that injury.

• Brand Name: 6506 MTS PWRPRO COT LOW CONFIG
• 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 Key: 13015144
• MDR Text Key: 283408984
• Report Number: 0001831750-2021-01650
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327513288
• UDI-Public: 07613327513288
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6506
• Device Catalogue Number: 650605550001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other