MAUDE Adverse Event Report: R. POON MEDICAL PRODUCTS COMPANY LTD CANE

Model Number XX

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2018

Event Type  malfunction  

Event Description

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• Brand Name: CANE
• Type of Device: CANE
• Manufacturer (Section D): R. POON MEDICAL PRODUCTS COMPANY LTD; no. 116 qicang road; mingguang, 23940 0; CH 239400
• MDR Report Key: 10307412
• MDR Text Key: 202018167
• Report Number: 1056127-2019-00100
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 06/13/2019

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: XX
• Device Catalogue Number: XX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 95