MAUDE Adverse Event Report: CRANIAL TECHNOLOGIES DOC CRANIAL BANDING HELMET

Model Number DOC BRAND CRANIAL BANDING HELMET

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Hematoma (1884); Scarring (2061); Complaint, Ill-Defined (2331); Injury (2348)

Event Date 05/22/2015

Event Type  Injury  

Event Description

Cranial banding helmet (cranial technologies doc brand) caused direct injury to (b)(6) infant.The moleskin adhesive applied to the interior of the helmet by cranial technologies clinician after helmet adjustment visit became undone and "rolled" onto itself during overnight sleep period causing a large forehead pressure wound with resultant hematoma, edema, and skin scarring.Additional pressure wounds on the lateral and posterior scalp also noted.

• Brand Name: DOC CRANIAL BANDING HELMET
• Type of Device: DOC CRANIAL BANDING HELMET
• Manufacturer (Section D): CRANIAL TECHNOLOGIES
• MDR Report Key: 4834840
• MDR Text Key: 18093571
• Report Number: MW5043010
• Device Sequence Number: 1
• Product Code: MVA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DOC BRAND CRANIAL BANDING HELMET
• Other Device ID Number: DOC BRAND
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 7 MO
• Patient Weight: 7