MAUDE Adverse Event Report: HOMECARE ENTERPRISE CO., LTD. DRIVE; CANE

Model Number RTL10372BK

Device Problem Material Fragmentation (1261)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a cane.Cane was not retrieved for evaluation.Cane snapped in half while in use.End-user fell and broke his glasses.

• Brand Name: DRIVE
• Type of Device: CANE
• Manufacturer (Section D): HOMECARE ENTERPRISE CO., LTD.; 5 lane 476 lunmei rd.; changhua city; changhua, 500 ; TW 500
• MDR Report Key: 10063484
• MDR Text Key: 191590815
• Report Number: 2438477-2020-00028
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00822383246451
• UDI-Public: 822383246451
• 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: 05/15/2020

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: RTL10372BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2020
• Distributor Facility Aware Date: 04/27/2020
• Device Age: 17 MO
• Date Report to Manufacturer: 05/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 86