MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. DRIVE MEDICAL; WALKER

Model Number	KA2200S-2GWP
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Swelling/ Edema (4577)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a posterior walker by an end user, who stated that the wheels to her walker became caught in a doorway, causing her to fall to the ground and sustain bruising, swelling, and bleeding to her face.The end user consulted a doctor after the incident to confirm that there was no further injury.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): BLISS HEALTH PRODUCTS CO., LTD.; no.61 & no.96, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 15995416
• Report Number: 2438477-2022-00126
• Device Sequence Number: 6209118
• Product Code: ITJ
• UDI-Device Identifier: 00822383583983
• UDI-Public: 822383583983
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2022
• Report Date (Section F): 12/14/2022

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: KA2200S-2GWP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/17/2022
• Date Report to Manufacturer: 12/21/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 38 KG
• Date Report Sent to FDA: 12/14/2022