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

Model Number	10247-4
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare received a complaint involving a walker from an end user, who reported that while using the walker, it "slid," causing her to fall.The end user stated that "with all the narcotics in her body, [she] shouldn't have to worry about the surfaces [she] walks on." she stated that to her knowledge "nothing on the unit is broken but left a skid mark on her floor." as a result of the fall, she hit the left side of her head and "ruptured her ear." drive is currently investigating the incident, including attempting to retrieve the product to evaluate it.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao st.; w district, no.6 workshop ii; zhongshan city, guangdong ; CH
• MDR Report Key: 15057719
• Report Number: 2438477-2022-00060
• Device Sequence Number: 5500887
• Product Code: ITJ
• UDI-Device Identifier: 50822383537257
• UDI-Public: 50822383537257
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/19/2022
• Report Date (Section F): 07/19/2022

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
• Device Model Number: 10247-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/08/2022
• Event Location: Home
• Date Report to Manufacturer: 07/21/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/19/2022