MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD DRIVE; WALKER

Model Number	10210-1
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Neck Pain (2433)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a walker from an end user, who reported that while recovering from spinal surgery, he was "using the walker when the back right leg bent and collapsed and hurt his neck and his back and will be seeking medical attention at his next doctor's appointment." drive has attempted to contact the end user to gather additional information and retrieve the product for evaluation, but there has been no response.Drive will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; 98, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 15363253
• Report Number: 2438477-2022-00054
• Device Sequence Number: 12501733
• Product Code: ITJ
• UDI-Device Identifier: 00822383117379
• UDI-Public: 822383117379
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2022
• Report Date (Section F): 09/06/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 10210-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/26/2022
• Event Location: Home
• Date Report to Manufacturer: 09/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 82 KG
• Date Report Sent to FDA: 09/06/2022