E-THOTIC 301

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 2014-06-27 for E-THOTIC 301 manufactured by Fixes 4 Kids.

Event Text Entries

[17389439] Skin breakdown and abrasions found on patient's arm with use of the e-thotic. Injuries found on f/u visits after surgery, usually a week after surgery. The reductions are great, it is the post-op when the e-thotic is placed on the child where the skin breakdown appears when the child comes back for check ups. Has happened in "no less than 5 cases, no more than 10 cases". They believe the area inside of the orthotic does not breathe well, causing moisture to build up inside.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2921578-2014-00016
• MDR Report Key: 3957767
• Report Source: 99
• Date Received: 2014-06-27
• Date of Report: 2014-06-27
• Date of Event: 2014-05-30
• Date Facility Aware: 2014-05-30
• Report Date: 2014-05-30
• Date Reported to Mfgr: 2014-05-30
• Date Added to Maude: 2014-07-28
• 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: 0
• Reporter Occupation: PHYSICIAN ASSISTANT
• 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: E-THOTIC
• Generic Name: SPLINT, EXTREMITY, NON-INFLATABLE, EXTERNAL, NON-STERILE
• Product Code: NOC
• Date Received: 2014-06-27
• Model Number: 301
• Catalog Number: 301
• Operator: OTHER
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FIXES 4 KIDS
• Manufacturer Address: 2200 15TH ST N WAHPETON ND 58075 US 58075

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2014-06-27