MAUDE Adverse Event Report: FOSHAN R. POON MEDICAL PRODUCTS CO., LTD ENDURANCE PYRAMID CANE

Model Number RPM70020

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2015

Event Type  malfunction  

Event Description

Dealer reported to sales rep that a pyramid cane had been returned with a broken leg.The user did not report an injury or fall.The contact information for the user was obsolete and no other contact information was found.

• Brand Name: ENDURANCE PYRAMID CANE
• Type of Device: PYRAMID CANE
• Manufacturer (Section D): FOSHAN R. POON MEDICAL PRODUCTS CO., LTD; new city district, donzao, nanhai, fosha 5282 16; CH 528216
• Manufacturer (Section G): ESSENTIAL MEDICAL SUPPLY, INC.; 6420 hazeltine national dr.; orlando FL 32822
• Manufacturer Contact: 6420 hazeltine national dr.; orlando, FL 32822
• MDR Report Key: 4827653
• MDR Text Key: 5843345
• Report Number: 1056127-2015-00013
• Device Sequence Number: 1
• Product Code: KHY
• 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: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RPM70020
• Device Catalogue Number: W1300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2015
• Distributor Facility Aware Date: 05/18/2015
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 06/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1