MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6252; STRETCHER, WHEELED

Catalog Number 6252000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated and no defect was identified.

Event Description

It was alleged that a user received a shoulder injury while transporting a patient.It was reported that the injury was due to the users partner turning the chair when the other user was not ready.The patient was not injured as a result of this event.Further information was not provided in regards to the user injury.

Manufacturer Narrative

The caregiver suffered a shoulder strain due to maneuvering the chair, however did not require any treatment.It was also confirmed that this issue was not due to any product defect or malfunction.

Event Description

It was alleged that a user received a shoulder injury while transporting a patient.It was reported that the injury was due to the users partner turning the chair when the other user was not ready.The patient was not injured as a result of this event.

• Brand Name: STAIR PRO - MODEL 6252
• 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: 8866566
• MDR Text Key: 153504354
• Report Number: 0001831750-2019-00894
• Device Sequence Number: 1
• Product Code: FPP
• 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,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2005
• 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