NATUS BILIBAND EYE PROTECTOR 900642, 900643

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-27 for NATUS BILIBAND EYE PROTECTOR 900642, 900643 manufactured by Natus Medical Incorporated.

Event Text Entries

[70907306] There is a "caution" in the biliband instructions for use that instruct the user to "avoid obstructing the nose and check regularly that this does not occur. " the instructions also include a diagram and instructions explaining proper positioning and fastening of the biliband. Review of complaint record determined there has been no customer report on the bilibands getting into infant's mouths in the past five years. This investigation is ongoing and additional information has been requested from the user facility. Samples from user facility requested.
Patient Sequence No: 1, Text Type: N, H10


[70907307] Natus received a customer complaint indicating that "three incidents where infants were able to get the bilibands into their mouths, almost choking. " investigation of the events concluded that improperly secured bilibands or improper sizing of the biliband causing a loose fit or overstretched product are the likely causes of the reported events.
Patient Sequence No: 1, Text Type: D, B5


[73924348] There is a "caution" in the biliband instructions for use that instruct the user to "avoid obstructing the nose and check regularly that this does not occur. " the instructions also include a diagram and instructions explaining proper positioning and fastening of the biliband. The customer provided natus a picture, which displays improper use of the biliband device. Investigation of these events has concluded that either improperly secured bilibands or improper sizing of the biliband causing a loose fit or overstretched product are the causes of the reported events. Review of complaint records determined there has been no customer report on the bilibands getting into infant's mouths in the past five years. The end user has been provided instructional documentation and training on the use of the biliband device after these reported events. Please note that additional information, such as patient information or date of event, were requested from the customer. This report is considered final and this investigation is concluded. Customer communication.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3018859-2017-00228
MDR Report Key6434974
Report SourceUSER FACILITY
Date Received2017-03-27
Date of Report2017-02-24
Date Mfgr Received2017-02-24
Date Added to Maude2017-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJEFFREY MANTKOWSKI
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal98108
Manufacturer Phone2062685143
Manufacturer G1NATUS MEDICAL INCORPORATED
Manufacturer Street5900 FIRST AVENUE SOUTH
Manufacturer CitySEATTLE WA 98108
Manufacturer CountryUS
Manufacturer Postal Code98108
Single Use3
Remedial ActionPM
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNATUS BILIBAND EYE PROTECTOR
Generic NameBILIBAND
Product CodeFOK
Date Received2017-03-27
Model Number900642, 900643
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INCORPORATED
Manufacturer Address5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-03-27

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