MAUDE Adverse Event Report: DRIVE / MEDICAL DEPOT INC. CRUTCH; TIPS AND PADS, CANE, CRUTCH AND WALKER

Model Number 104001-1

Patient Problem Fall (1848)

Event Date 11/06/2023

Event Type  Injury  

Event Description

Patient used drive crutches after having had foot surgery.The crutch malfunctioned resulting in her falling and injuring herself.

• Brand Name: CRUTCH
• Type of Device: TIPS AND PADS, CANE, CRUTCH AND WALKER
• Manufacturer (Section D): DRIVE / MEDICAL DEPOT INC.
• MDR Report Key: 18247208
• MDR Text Key: 329569921
• Report Number: MW5148638
• Device Sequence Number: 1
• Product Code: INP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/28/2023

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 Operator: Lay User/Patient
• Device Model Number: 104001-1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American