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

Model Number KA2200S-2GWP

Device Problem Failure to Align (2522)

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

Event Date 09/02/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 305596914
• Report Number: 2438477-2022-00126
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383583983
• UDI-Public: 822383583983
• 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: 12/14/2022,12/16/2022

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