InjuryMVA
DOC CRANIAL BANDING HELMET
Received Jun 2, 2015 · Event occurred May 22, 2015
Report MW5043010 · MDR key 4834840
Device
Generic name
Doc Cranial Banding Helmet
Manufacturer
Cranial TechnologiesModel number
DOC BRAND CRANIAL BANDING HELMETProduct problems
- Device Operates Differently Than Expected
Patient
7 MO
- Edema
- Hematoma
- Scarring
- Complaint, Ill-Defined
- Injury
Narrative
Description of Event or Problem
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.