MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL DRIVE DEVILBISS HEALTHCARE; TIPS AND PADS, CANE, CRUTCH AND WALKER

Model Number	404722
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a walker by the end user's husband who stated that his wife "swung" the walker around and hit her leg with the glide ski resulting in a laceration.The end user received medical treatment for the laceration and was prescribed antibiotics.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: TIPS AND PADS, CANE, CRUTCH AND WALKER
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL; no. 98 zhaoyi road; dongsheng town; zhongshan city, zhongshan 52841 4; CH 528414
• MDR Report Key: 19763896
• Report Number: 2438477-2024-00034
• Device Sequence Number: 8513122
• Product Code: INP
• UDI-Device Identifier: 10311917221066
• UDI-Public: 10311917221066
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2024
• Report Date (Section F): 07/17/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 404722
• Device Catalogue Number: 404722
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/28/2024
• Event Location: Home
• Date Report to Manufacturer: 07/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/17/2024