MAUDE Adverse Event Report: HOMECARE ENTERPRISE CO. LTD. DESIGNER QUAD CANE

Model Number C-604S-CD04

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 01/14/2019

Event Type  malfunction  

Event Description

Per dealer, end user was using cane normally when shaft broke and end user fell.No injuries were reported.Dealer refused to give information on end user.Data for eu is approximate.

• Brand Name: DESIGNER QUAD CANE
• Type of Device: QUAD CANE
• Manufacturer (Section D): HOMECARE ENTERPRISE CO. LTD.; no. 11 changsheng st; huatan township; changhua county, taiwan 50347 ; TW 50347
• MDR Report Key: 8292749
• MDR Text Key: 134594971
• Report Number: 1056127-2019-00001
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00754756913052
• UDI-Public: 754756913052
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: C-604S-CD04
• Device Catalogue Number: W1303I
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2019
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 01/31/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 91