MAUDE Adverse Event Report: PINGHU WEIFENG MATERIAL TECHNOLOGY NARROW BASE QUAD CANE 1616710022

Model Number 3920-2

Device Problem Fracture (1260)

Patient Problem Bruise/Contusion (1754)

Event Type  Injury  

Event Description

End user is stating the following: that he has a defective model 3920-2, stating that he was walking with his wife in their neighborhood on dry level sidewalk when for no reason the four pronged cane came apart and the end user fell down making his wife fall on the ground also.End user is alleging that he had bruised ribs from the fall.Update from consumer affairs on 04/19/2016: end user called back and sent photos of the broken cane.The dealer picked up the cane but did not return it to us and location of product is unknown at this time.They think it was thrown away when they exchanged it.End user said he was just walking along and it snapped in half and he fell on his wife.No broken bones but he was sore and had an x-ray done to confirm he did not break anything.End user had soreness and bruising.No further information provided or expected at this time.

• Brand Name: NARROW BASE QUAD CANE 1616710022
• Type of Device: CANE
• Manufacturer (Section D): PINGHU WEIFENG MATERIAL TECHNOLOGY; pinghu ; CH
• MDR Report Key: 5650852
• MDR Text Key: 45065330
• Report Number: 1531186-2016-00012
• Device Sequence Number: 1
• Product Code: KHY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/29/2016,04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3920-2
• 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: 04/29/2016
• Distributor Facility Aware Date: 04/19/2016
• Device Age: 13 YR
• Date Report to Manufacturer: 04/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 88