GUARDIAN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-03-11 for GUARDIAN manufactured by .

Event Text Entries

[5465242] Via notice to file suit, it is being alleged that on (b)(6) 2013 an adverse event involving a set of guardian crutch tips occurred. The end-user stated while walking into his kitchen, the crutch tips gave way, causing him to fall. As a result, the end-user is alleging permanent injuries to his shoulder and hand. Due to legal involvement additional information is unavailable at this time. Due to legal involvement the severity of the injuries sustained by the end-user are unknown. Information regarding the model number of the crutch tips and who manufactured them is still undetermined. Our legal team is working to obtain the necessary information so that a supplemental mdr can be filed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3006459587-2015-00001
• MDR Report Key: 4605415
• Report Source: 99
• Date Received: 2015-03-11
• Date of Report: 2015-02-10
• Date of Event: 2013-02-01
• Date Facility Aware: 2015-02-10
• Report Date: 2015-03-06
• Date Reported to Mfgr: 2015-03-06
• Date Added to Maude: 2015-03-17
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GUARDIAN
• Generic Name: GUARDIAN CRUTCH TIPS
• Product Code: INP
• Date Received: 2015-03-11
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-03-11