MAUDE Adverse Event Report: SKYMED SUPPLY INTERNATIONAL CORPORATION BIG FOOT CANE TIP

Model Number SM-017003B

Device Problem Crack (1135)

Patient Problems Fall (1848); No Information (3190)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

User fell while using cane.Complainant would not give details about patient's, weight, age, medical condition before and after event.He alluded to injury but refused to cooperate with investigation.This medwatch report is being file in an abundance of caution.

• Brand Name: BIG FOOT CANE TIP
• Type of Device: CANE TIP
• Manufacturer (Section D): SKYMED SUPPLY INTERNATIONAL CORPORATION; 6905 aragon circle; buena park CA 90620
• MDR Report Key: 9306694
• MDR Text Key: 197943401
• Report Number: 1056127-2019-00004
• Device Sequence Number: 1
• Product Code: INP
• UDI-Device Identifier: 00754756130947
• UDI-Public: 754756130947
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2019,10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SM-017003B
• Device Catalogue Number: T20009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2019
• Distributor Facility Aware Date: 10/14/2019
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 11/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR