FDA.reportPublic FDA data

MAUDE MDR 8423580

MDR report key
8423580
Report number
3018859-2019-00002
Event key
0
Event type
3
Date of event
2018-04-16
Date received
2019-03-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
JAMES FITZGERALD
Address
5900 FIRST AVE SOUTH SEATTLE WA 98108 US
Phone
206-206-2062
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NATUS BILIBAND EYE PROTECTORBILIBANDNATUS MEDICAL INC.FOKN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-1501. O

Event Narratives#

N

Patient 1

NATUS TECHNICAL SERVICE REQUESTED FDA CONTACT FOR MORE INFORMATION TO INVESTIGATE THE INCIDENT FURTHER, AND FDA WAS UNABLE TO RELEASE ANY FURTHER INFORMATION THAT PERTAINS TO THE REPORT IN QUESTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE NATUS WILL FILE A SUPPLEMENTAL REPORT.

D

Patient 1

NATUS MEDICAL RECEIVED MEDWATCH REPORT NUMBER MW5083472 FROM THE FDA ON 13 FEB 2019. THE REPORT WAS SUBMITTED BY A PATIENT'S PARENT REGARDING AN ALLEGED EVENT INVOLVING THE NATUS BILIBAND EYE PROTECTOR. THE ALLEGED EVENT OCCURRED ON (B)(6) 2018, WHEN A NEWBORN BABY WAS RECEIVING TREATMENT FOR JAUNDICE AND WEARING A BILIBAND. AN HOUR AFTER A BILIBAND WAS APPLIED TO THE PATIENT THE MOTHER OF THE PATIENT STATED SHE OBSERVED THAT THE BILIBAND HAD SLID DOWN BENEATH THE EYES AND WAS COVERING THE BABY'S NOSE AND MOUTH. THE MOTHER ALLEGED THAT THE FOAM-LIKE EYE-PAD MATERIAL APPEARED TO BE TIGHTLY PRESSED AGAINST THE BABY'S NOSE AND MOUTH AND SHE BELIEVED THAT THE EYE PROTECTOR WAS CAUSING ASPHYXIATION. SHE QUICKLY OPENED THE INCUBATOR AND POSITIONED THE BILIBAND EYE PROTECTOR BACK ON THE EYES AND WITNESSED THE BABY'S NOSTRILS RAPIDLY FLARE TWICE BEFORE THE CHILD WENT TO SLEEP. NATUS TECHNICAL SERVICE REQUESTED MORE INFORMATION FROM THE FDA HOWEVER, THE FDA WAS UNABLE TO RELEASE ANY FURTHER INFORMATION.