MAUDE MDR 690552

MDR report key
690552
Report number
MW1038148
Event key
0
Event type
3
Date of event
2005-06-01
Date received
2006-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HANGER CRANIAL HELMETCRANIAL HELMETHANGERMVA***N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-02-2701. S

Event Narratives#

D

Patient 1

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.