MAUDE Adverse Event Report: AID-PRO HEALTHCARE CO., LTD. CAREX; CANE

Model Number FGA74100 0000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 08/27/2018

Event Type  Injury  

Event Description

The end-user sustained severe & disfiguring personal injuries when the base of a quad cane lacerated her leg.Information regarding the model number of the quad cane has not been reported.

Event Description

Update to event information identified on (b)(6) 2019: based on identifying features in the photos provided, the cane involved with this event has been identified as likely being the fga74100 0000 carex offset designer quad cane.Lot# information remains unavailable at this time.Supplier of cane has been updated to aid-pro healthcare, or now com-da.

• Brand Name: CAREX
• Type of Device: CANE
• Manufacturer (Section D): AID-PRO HEALTHCARE CO., LTD.; no. 58 yu long 3 road; dong sheng town; zhong shan city, ; CH
• MDR Report Key: 8206266
• MDR Text Key: 131716863
• Report Number: 3012316249-2018-00067
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA74100 0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2019
• Distributor Facility Aware Date: 01/08/2019
• Event Location: Home
• Date Report to Manufacturer: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention