MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; WALKER

Model Number	10200-1
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a walker by and end user's wife, who stated "her husband fell down" while using the walker.The reporter stated that the walker's leg was bent, but was unsure whether the leg was bent prior to the fall, or as a result of the fall.She confirmed that her husband did not sustain any injuries, and did not seek any medical treatment.Drive will continue to monitor complaints for any related trends.
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a walker by and end user's wife, who stated "her husband fell down" while using the walker.The reporter stated that the walker's leg was bent, but was unsure whether the leg was bent prior to the fall, or as a result of the fall.She confirmed that her husband did not sustain any injuries, and did not seek any medical treatment.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no 1 jinzhao st, west district; no. 6 workshop ii; zhongshan city, guangdong ; CH
• MDR Report Key: 17019119
• Report Number: 2438477-2023-00048
• Device Sequence Number: 6286008
• Product Code: ITJ
• UDI-Device Identifier: 00822383117331
• UDI-Public: 00822383117331
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 06/01/2023
• Report Date (Section F): 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10200-1
• Device Catalogue Number: 10200-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2023
• Event Location: Home
• Date Report to Manufacturer: 05/31/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 05/30/2023