MAUDE Adverse Event Report: FOSHAN NANHAI R. POON MEDICAL PRODUCTS CO., LTD. SURE GRIP ORTHO CANE

Model Number RPM79030-BRZ

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Event Description

End user was walking with a cane when the shaft snapped.There was no fall or injury.

• Brand Name: SURE GRIP ORTHO CANE
• Type of Device: CANE
• Manufacturer (Section D): FOSHAN NANHAI R. POON MEDICAL PRODUCTS CO., LTD.; new city district; danzao, nanhai; foshan, guangdong 52821 6; CH 528216
• Manufacturer (Section G): FOSHAN NANHAI R. POON MEDICAL PRODUCTS CO., LTD.; new city district; danzao, nanhai; foshan, guangdong 52821 6; CH 528216
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 7706266
• MDR Text Key: 114802921
• Report Number: 1000282279-2018-00001
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00754756914530
• UDI-Public: 754756914530
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RPM79030-BRZ
• Device Catalogue Number: W1448BR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 113