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

Model Number	10243
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	05/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a walker from the end user, who reported that she "tried to sit on walker, and the back strap broke.She fell and hit her head on the concrete, and her elbow was also bleeding.Her hip was also injured." the end user did not go to the emergency room but sought medical treatment with her primary physician, who advised her to rest.X-rays of her hip were negative.The end user declined to return the unit to drive for evaluation.

• 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: 15363427
• Report Number: 2438477-2022-00055
• Device Sequence Number: 12485065
• Product Code: ITJ
• UDI-Device Identifier: 00822383138107
• UDI-Public: 822383138107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 10243
• 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: Female
• Date Report Sent to FDA: 09/06/2022