MAUDE Adverse Event Report: DURO MED INDUSTRIES / DMS HOLDINGS, INC. ; WALKER, MECHANICAL

Model Number 500-1044-0100

Device Problem Break (1069)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 11/30/2018

Event Type  Injury  

Event Description

During an ambulation, screws broke on left side fall brace, resulting in pt pitching to the side and falling.Fall resulted in hip fracture operative procedure.

• Brand Name: UNK
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DURO MED INDUSTRIES / DMS HOLDINGS, INC.
• MDR Report Key: 8180869
• MDR Text Key: 131302564
• Report Number: MW5082292
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/10/2018

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?: No
• Device Operator: No Information
• Device Model Number: 500-1044-0100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 61