MAUDE Adverse Event Report: HEALTHPLUS QUICK CHANGE CRUTCH TALL ADULT 9153618191; TIPS AND PADS, CANE, CRUTCH AND WALKE

Model Number 8115-T

Device Problems Break (1069); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer alleges that the crutch has snapped at the rivet.

• Brand Name: QUICK CHANGE CRUTCH TALL ADULT 9153618191
• Type of Device: TIPS AND PADS, CANE, CRUTCH AND WALKE
• Manufacturer (Section D): HEALTHPLUS; handan ; CH
• MDR Report Key: 4406836
• MDR Text Key: 18777431
• Report Number: 1531186-2015-00159
• Device Sequence Number: 1
• Product Code: INP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/08/2015,12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8115-T
• 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: 01/08/2015
• Distributor Facility Aware Date: 12/22/2014
• Date Report to Manufacturer: 01/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other