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

Catalog Number UNK_MED

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

Patient Problem Injury (2348)

Event Date 01/15/2019

Event Type  Injury  

Event Description

It was alleged that a transport employee incurred a hand/wrist injury while using the device at work.

Manufacturer Narrative

It was originally reported that a user incurred a hand/wrist injury, however upon completion of the event investigation it was identified to be a foot injury.As a result of this reported event, a stryker quality assurance engineer spoke with a representative at the user facility who stated that 2 transporters were moving a stretcher with a patient when the transporter at the head end stopped moving and the transporter at the foot end continued to push the stretcher, which resulted in the 1 transporter running over the foot of the other transporter.The injured transporter had an x-ray which showed a hairline fracture to their toe.The transporter did not need a cast but did require medical treatment and was not able to work for a few days.The user facility did not know the exact model or serial number of the unit, but stated that it was a prime stretcher and that there were no defects with the stretcher.

Event Description

It was alleged that a transport employee incurred a foot injury while using the device at work.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• 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: 8337525
• MDR Text Key: 136108577
• Report Number: 0001831750-2019-00268
• Device Sequence Number: 1
• Product Code: FPO
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2019
• 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