MAUDE Adverse Event Report: HOMECARE ENTERPROSE CO. LTS HUGO; CANE

Model Number	731-850
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a cane.The unit has not been returned for evaluation.We will file a follow-up submission when more data becomes available.We are filing third report in an over-abundance of caution.While in use one of the four feet bent causing the end-user to fall.He received cuts on his arms and a pain in his hip.He did not go to the hospital for treatment.He is recovering from hip surgery.

• Brand Name: HUGO
• Common Device Name: CANE
• Manufacturer (Section D): HOMECARE ENTERPROSE CO. LTS; no. 5, lane 476; lunmei road; changhua city, changhua 500 ; TW 500
• MDR Report Key: 11456857
• Report Number: 2438477-2021-00009
• Device Sequence Number: 3523520
• Product Code: IPS
• UDI-Device Identifier: 00754021210220
• UDI-Public: 754021210220
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/10/2021
• Report Date (Section F): 03/10/2021

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: 731-850
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/03/2021
• Device Age: 1 YR
• Date Report to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2021
• 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: 71 YR
• Patient Weight: 82
• Date Report Sent to FDA: 03/10/2021