MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME 5TH WHEEL STRETCHER 26IN; STRETCHER, WHEELED

Model Number 1105

Device Problem Mechanical Jam (2983)

Patient Problems Inflammation (1932); Pain (1994); Insufficient Information (4580)

Event Date 05/19/2022

Event Type  Injury  

Event Description

It was reported that the brake is difficult to engage/disengage from the side pedal.It was further reported that a user sustained an unknown injury as a result.Attempts are being made to gather additional details from the user facility.

Manufacturer Narrative

The investigation is complete.The executive summary and section h codes have been updated to reflect the investigation results.

Event Description

It was reported that the brake is difficult to engage/disengage from the side pedal.It was further reported that a user experienced back, hip, and groin pain after attempting to engage the brake.After examination, it was found the user had a twisted pelvis and inflamed hip joint, and the user received physiotherapy to treat the injuries.

• Brand Name: PRIME 5TH WHEEL STRETCHER 26IN
• 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 14518711
• MDR Text Key: 292797367
• Report Number: 0001831750-2022-00581
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278149
• UDI-Public: 07613327278149
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1105
• Device Catalogue Number: 1105000026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: No
• 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