MAUDE Adverse Event Report: JAN MAO INDUSTRIES CO., LTD DRIVE MEDICAL; CANE

Model Number 10339R-1

Device Problem Detachment Of Device Component (1104)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/01/2016

Event Type  Injury  

Event Description

Drive devilbiss healthcare received notice regarding the incident from the enduser's husband, involving a cane, a product imported and distributed by drive devilbiss healthcare.While using the cane, the handle of the cane broke causing her to allegedly jam her wrist into the stem of the cane.An x-ray was taken which showed that her wrist was fractured.A cast was put on and it will remain in place for at least six weeks.This report is based on the information that was provided by the enduser's husband.

• Brand Name: DRIVE MEDICAL
• Type of Device: CANE
• Manufacturer (Section D): JAN MAO INDUSTRIES CO., LTD; no. 181, chu liao rd; kao hsiung city, ta su district 84045 ; CH 84045
• MDR Report Key: 6018916
• MDR Text Key: 57053466
• Report Number: 2438477-2016-00047
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/11/2016,09/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10339R-1
• 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: 10/11/2016
• Distributor Facility Aware Date: 09/11/2016
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 10/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 91