MAUDE Adverse Event Report: HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED CO DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	1239RD
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a walker by the end user, who reported that she "cut her leg open on the screw from the folding hinge on the front right above the caster." the wound was treated by a specialist for skin grafts.Drive devilbiss healthcare is currently investigating the incident, including attempting to retrieve the device for investigation.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED CO; liaoan village, wanshi town; fuyang district; hangzhou city, zhejiang 31140 6; CH 311406
• MDR Report Key: 18016169
• Report Number: 2438477-2023-00133
• Device Sequence Number: 6537664
• Product Code: ITJ
• UDI-Device Identifier: 00822383537580
• UDI-Public: 00822383537580
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/26/2023
• Report Date (Section F): 10/26/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1239RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2023
• Event Location: Home
• Date Report to Manufacturer: 10/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Date Report Sent to FDA: 10/26/2023