N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-14 for N/A manufactured by N/a.

Event Text Entries

[72840437] The carex health brands (b)(6) page received a comment, stating the following, "my friend's mom fell on her cane like this, and the front of her leg is gouged wide open where it hit the base of the cane, she needed an ambulance, lost a great deal of blood and required stitches and stay in icu - her daughter used a foam pool noodle to wrap around the base (of the cane) to cover the sharp edges. " there is no infomation to get in touch with the end-user - don't even know what item it is. The customer service representative working with this case even googled the comment-poster's name, but nothing came up.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3012316249-2017-00043
• MDR Report Key: 6493498
• Date Received: 2017-04-14
• Date of Report: 2017-04-14
• Date Facility Aware: 2017-03-16
• Report Date: 2017-04-14
• Date Reported to FDA: 2017-04-14
• Date Added to Maude: 2017-04-14
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: N/A
• Generic Name: CANE
• Product Code: IPS
• Date Received: 2017-04-14
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: N/A
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: N/A
• Manufacturer Address: N/A N/A N/A US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-04-14