MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NATUS BILIBAND EYE PROTECTOR

Model Number 900642 , 900643

Device Problems Device Emits Odor (1425); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

This report is for incident #1.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 #900642 and #900643 were involved.Customer was not able to provide natus with lot numbers for the product involved in these incidents.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: NATUS BILIBAND EYE PROTECTOR
• Type of Device: BILIBAND
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• Manufacturer Contact: jeffrey mantkowski ; 5900 first avenue south; seattle, WA 98108 ; 2062685143
• MDR Report Key: 5961761
• MDR Text Key: 55119221
• Report Number: 3018859-2016-00015
• Device Sequence Number: 1
• Product Code: FOK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 900642 , 900643
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other