MalfunctionNDA
PLAGIOCEPHY HELMET
Received Oct 29, 2002
Report MW4003403 · MDR key 435446
Product problems
- Nonstandard Device
Patient
NO INFO
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
RPTR STATED THAT DR AT THE REFERENCED CLINIC HAS DEVELOPED AND IS USING A SPECIAL HELMET DESIGNED TO CORRECT PLAGIOCEPHALY IN THE CHILDRENS WARD OF THE HOSPITAL. RPTR ALSO STATED THAT THE REFERENCED DEVICE IS NOT FDA APPROVED.