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

Model Number 1239RD

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 08/05/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 326652715
• Report Number: 2438477-2023-00133
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383537580
• UDI-Public: 00822383537580
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 1239RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2023
• Distributor Facility Aware Date: 09/13/2023
• Event Location: Home
• Date Report to Manufacturer: 10/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 77 KG