HANGER CRANIAL HELMET *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-27 for HANGER CRANIAL HELMET * manufactured by Hanger.

Event Text Entries

[437124] Rptr's son is a victim of an ill fitting hanger cranial helmet. Dr recommended that he wear a hanger cranial helmet -not fda approved, but allowed due to being similar to cranial technologies docband-to correct his plagiocephally -skull deformity- pt became a victim at the hands of an inexperienced ortho. The ortho used a hanger insignia scanner - that is not fda approved- to scan son's head. The images are sent to a computer and from the images a cranial helmet is made. The helmet came back and was not a proper fit. The ortho tried to make the helmet that was too small from the begining fit on the pt's head. After weeks and weeks of complaints and taking pt back for helmet adjustments. Pt's head began to worsen in the helmet. His head/skull started taking the form of the too small helmet. Rather than pt's head growing outwards his head started growing upwards, thus resulting in add'l cranial height. The ortho continued to make improper adjustments to helmet that continue to make it even more ill fitting. Pt developed an additional deformity on the right side of his head. To make matters worse starting to think its due to the lasers from the insignia scanner being shined into his eyes. Rpt asks why clinical studies/trials weren't done on hanger cranial helmets and the insignia scanner. Rptr feels child is now paying the price.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1038148
• MDR Report Key: 690552
• Date Received: 2006-02-27
• Date of Report: 2006-02-27
• Date of Event: 2005-06-01
• Date Added to Maude: 2006-03-23
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HANGER CRANIAL HELMET
• Generic Name: CRANIAL HELMET
• Product Code: MVA
• Date Received: 2006-02-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 679700
• Manufacturer: HANGER
• Manufacturer Address: * ONTARIO CA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2006-02-27