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 with the FDA on 2016-09-19 for NATUS BILIBAND EYE PROTECTOR 900642 , 900643 manufactured by Natus Medical Incorporated.

Event Text Entries

[55111136] Customer stated that they have not recorded lot number of the product involved. Customer stated they have samples at the hospital and will be able to send them for investigation, but it is unknown if the samples are from the same lot involved in the incident reported. Natus medical currently waiting for product to be returned. When product is returned and evaluated, a follow-up report will be submitted. Pending product return.
Patient Sequence No: 1, Text Type: N, H10


[55111137] This report is for incident #3. Customer reported that they are aware of 5 incidents of patients experiencing skin rash. The rash was present on the entire area that would come into contact with the blue foam portion on the periorbital area of the infants. There was no rash under the white elastic securing portion. The skin became reddened. There were no blisters, open lesions, or drainage from the skin. Small raised bumps were noted on the skin where it was reddened. In two of the situations, phototherapy treatment had to be stopped early as the rash was so severe. There were no other interventions or treatments done as a result. No other abnormalities were noted. Customer is unsure of the part number of bilibands, but believes that #(b)(6) were involved. Customer was not able to provide natus with lot numbers for the product involved in these incidents.
Patient Sequence No: 1, Text Type: D, B5


[73687952] In addition to reports of contact dermatitis, a strong acidic chemical smell was reported when opening the box of biliband products. The customer was able to provide natus products from the same lot in question for investigation. A non-scientific approach of smelling the clear plastic packages upon opening was used to check if a similar odor could be detected. No such smell was noted. It is possible that the odor had been slowly released through the non-airtight package during shipping and storage. Production documents were requested and subsequently provided by the supplier. The following documentation was provided: bill of materials for biliband, biocompatability report, plain film sgs report, process flow of manufacturing biliband and "veclor" material safety data sheet. A review of the listed documentation did not reveal any suspicious source of an odor, and this investigation has been determined to be inconclusive. A search of similar complaints resulted in one similar complaint. In this case, the customer was unresponsive and the device was not returned for evaluation. Any report of similar complaints will be investigated by natus immediately. Please note that additional information, such as patient information, was requested from the customer with no response.
Patient Sequence No: 1, Text Type: N, H10


[73687953] The customer reported that they are aware of 5 incidents of patients experiencing skin rash. The rash was present on the entire area that would come into contact with the blue foam portion on the periorbital area of the infants. There was no rash under the white elastic securing portion. The skin became reddened. There were no blisters, open lesions, or drainage from the skin. Small raised bumps were noted on the skin where it was reddened. In two of the situations, phototherapy treatment had to be stopped early as the rash was so severe. There were no other interventions or treatments done as a result. No other abnormalities were noted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3018859-2016-00017
MDR Report Key5961710
Date Received2016-09-19
Date of Report2016-08-23
Date Mfgr Received2016-08-23
Date Added to Maude2016-09-19
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
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNATUS BILIBAND EYE PROTECTOR
Generic NameBILIBAND
Product CodeFOK
Date Received2016-09-19
Model Number900642 , 900643
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INCORPORATED
Manufacturer Address5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-09-19

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