CRANIAL ORTHOTIC STARBAND HELMET

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-01 for CRANIAL ORTHOTIC STARBAND HELMET manufactured by Orthomerica.

Event Text Entries

[20837496] On the morning of day 4, (b)(6), upon removing the cranial remolding helmet, numerous bloody abrasions revealed on the infant's head: one large on the right side near the ear, and multiple abrasions on the right fore head. The facility did not provide an informed consent describing the potential for such adverse events. The technician, not medical staff, instructed the parent to apply cortisone and stop wearing the helmet. When contacting a medical nurse for a second opinion, the nurse corrected the technician stating that one should not apply cortisone to the open bleeding sore on the infant's head. Each attempt to use the helmet results in abrasions and the facility instructs to not use the helmet until the skin heals, which takes about 3 weeks. Each attempt results in new abrasions. Due to the infant's rapid growth, the helmet does not fit properly and the technician instructed to continue attempting to use the helmet that does not fit and persists to injure the infant's head. The technician did not offer another helmet or other solution, just insisted that if we didn't use that particular helmet, then the infant will have a misshaped head. Dates of use: (b)(6)2010- (b)(6)2010. Diagnosis or reason for use: plagiocephaly. Event abated after use: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5017321
• MDR Report Key: 1828647
• Date Received: 2010-09-01
• Date of Report: 2010-09-01
• Date of Event: 2010-04-22
• Date Added to Maude: 2010-09-14
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CRANIAL ORTHOTIC STARBAND HELMET
• Generic Name: CRANIAL REMOLDING HELMET
• Product Code: MVA
• Date Received: 2010-09-01
• Lot Number: XXX
• ID Number: XXX
• Operator: OTHER
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ORTHOMERICA
• Manufacturer Address: 6333 N. ORANGE BLOSSOM TRAIL SUITE 220 ORLANDO FL 32810 US 32810

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2010-09-01