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

Catalog Number 6252000000

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 08/05/2023

Event Type  Injury  

Event Description

It was reported the folding device was accidentally left unlocked.It was further reported that a user's fingertip got caught in the device and the fingertip was partially amputated.It was treated immediately with a compression bandage after completion of the procedure.

Manufacturer Narrative

The device was evaluated by a stryker field service technician and it was found that the pinch crush point was not due to a component level malfunction.The pinch crush point was caused by the user not locking the chair properly.

Event Description

It was reported the folding device was accidentally left unlocked.It was further reported that a user's fingertip got caught in the device and the fingertip was partially amputated.It was treated immediately with a compression bandage after completion of the procedure.

• Brand Name: STAIR PRO - MODEL 6252
• Type of Device: STRETCHER, HAND-CARRIED
• 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: 17701264
• MDR Text Key: 322876814
• Report Number: 0001831750-2023-00996
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2011
• 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