MAUDE Adverse Event Report: GUARDIAN; GUARDIAN CRUTCH TIPS

Device Problem Break (1069)

Patient Problems Fall (1848); Injury (2348)

Event Date 02/01/2013

Event Type  Injury  

Event Description

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.

• Brand Name: GUARDIAN
• Type of Device: GUARDIAN CRUTCH TIPS
• MDR Report Key: 4605415
• MDR Text Key: 5465242
• Report Number: 3006459587-2015-00001
• Device Sequence Number: 1
• Product Code: INP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/06/2015,02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/10/2015
• Event Location: Home
• Date Report to Manufacturer: 03/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention