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

Model Number KA1200-2GKB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bruise/Contusion (1754); Fall (1848); Swelling/ Edema (4577)

Event Date 04/28/2023

Event Type  Injury  

Event 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
• Type of Device: WALKER
• Manufacturer (Section D): JAN MAO INDUSTRIES CO., LTD.; pingguo city; industrial zone baise; guangxi 53140 0; CH 531400
• MDR Report Key: 17011305
• MDR Text Key: 316032465
• Report Number: 2438477-2023-00049
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383583815
• UDI-Public: 00822383583815
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: KA1200-2GKB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2023
• Distributor Facility Aware Date: 04/28/2023
• Device Age: 2 YR
• Date Report to Manufacturer: 06/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 MO
• Patient Sex: Male
• Patient Weight: 14 KG