MAUDE Adverse Event Report: JAN MAO INDUSTRIES CO., LTD. DRIVE MEDICAL; WALKER

Model Number	KA1200-2GKB
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Swelling/ Edema (4577)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a pediatric posterior walker by an end user's mother, who stated that "the wheels locked in the front," causing her son to fall and the walker to fall on top of him, resulting in "a large goose egg on his forehead." the end user did not receive medical treatment and the injury resolved in 4 days.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE MEDICAL
• Common Device Name: WALKER
• Manufacturer (Section D): JAN MAO INDUSTRIES CO., LTD.; pingguo city; industrial zone baise; guangxi 53140 0; CH 531400
• MDR Report Key: 17011305
• Report Number: 2438477-2023-00049
• Device Sequence Number: 6872916
• Product Code: ITJ
• UDI-Device Identifier: 00822383583815
• UDI-Public: 00822383583815
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2023
• Report Date (Section F): 05/26/2023

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: KA1200-2GKB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2023
• Device Age: 2 YR
• Date Report to Manufacturer: 06/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 MO
• Patient Sex: Male
• Patient Weight: 14 KG
• Date Report Sent to FDA: 05/26/2023