MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER LOAD; STRETCHER, WHEELED

Model Number 6390

Device Problem Device Fell (4014)

Patient Problems Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 11/18/2021

Event Type  Injury  

Event Description

It was reported that during unloading, the cot dropped.It was further reported that as a result, a user sustained a back injury and was taken to urgent care.The user is now being treated with physical therapy.

Event Description

It was reported that during unloading, the cot dropped.It was further reported that as a result, a user sustained a back strain and was taken to urgent care.The user is now being treated with physical therapy.

Manufacturer Narrative

Investigation is complete.Patient codes updated to reflect the injury details.

Manufacturer Narrative

This supplemental is being filed to correct the type of event to both product problem and adverse event/serious injury.

Event Description

It was reported that during unloading, the cot dropped.It was further reported that as a result, a user sustained a back strain and was taken to urgent care.The user is now being treated with physical therapy.

• Brand Name: POWER LOAD
• 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: 12984298
• MDR Text Key: 282114483
• Report Number: 0001831750-2021-01647
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261523
• UDI-Public: 07613327261523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113598
• 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,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6390
• Device Catalogue Number: 6390000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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