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

Model Number 731-850

Device Problem Material Fragmentation (1261)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 03/03/2021

Event Type  Injury  

Event 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
• Type of Device: CANE
• Manufacturer (Section D): HOMECARE ENTERPROSE CO. LTS; no. 5, lane 476; lunmei road; changhua city, changhua 500 ; TW 500
• MDR Report Key: 11456857
• MDR Text Key: 239393411
• Report Number: 2438477-2021-00009
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00754021210220
• UDI-Public: 754021210220
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 731-850
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2021
• Distributor Facility Aware Date: 03/03/2021
• Device Age: 1 YR
• Date Report to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 82