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

Catalog Number UNK_MED

Device Problem Device Fell (4014)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946); Muscle/Tendon Damage (4532)

Event Date 01/20/2021

Event Type  Injury  

Event Description

It was reported that the caregiver was treating a larger patient in the emergency department when the patient experienced a cardiac event.There was a fowler collapse and the caregiver reached under the backrest to attempt to stop the fowler from falling.The caregiver's arm allegedly became caught and the force of the collapsing fowler reportedly cut into his skin, severed his bicep, and broke his arm.

Manufacturer Narrative

The b5 summary and section h codes have been updated to reflect the completed investigation.

Event Description

It was reported that the caregiver was treating a larger patient in the emergency department on an unspecified stretcher when the patient experienced a cardiac event.There was a fowler collapse and the caregiver reached under the backrest to attempt to stop the fowler from falling.The caregiver's arm allegedly became caught and the force of the collapsing fowler reportedly cut into his skin, severed his bicep, and broke his arm.

• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 14461045
• MDR Text Key: 292578589
• Report Number: 0001831750-2022-00574
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 06/23/2022
• 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