MAUDE Adverse Event Report: RAISE MEDICAL INDUSTRIES, INC. WALGREENS; CANE

Model Number 271063

Device Problem Collapse (1099)

Patient Problem Laceration(s) (1946)

Event Date 03/25/2016

Event Type  Injury  

Event Description

Drive medical received a notice of incident which involved a quad cane that drive medical has been sourcing for (b)(6).The end user was using the cane while going down the three wide concrete steps of their property.As he came to the bottom step, one of the prongs of the cane bent inward.The cane tore his leg as he was falling.His left leg was allegedly wounded from knee to half way down his shin.This report is based solely on the information provided by the wife of the end user.

• Brand Name: WALGREENS
• Type of Device: CANE
• Manufacturer (Section D): RAISE MEDICAL INDUSTRIES, INC.; phase 1, jiangli north road; nansha industrial village; foshan city, guangdong 52821 6; CH 528216
• MDR Report Key: 5748572
• MDR Text Key: 48137517
• Report Number: 2438477-2016-00024
• Device Sequence Number: 1
• Product Code: KHY
• 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: 06/09/2016,05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 271063
• Device Catalogue Number: 271063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2016
• Device Age: 16 MO
• Event Location: Home
• Date Report to Manufacturer: 06/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 110