MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-15 for NATUS BILIBAND EYE PROTECTOR manufactured by Natus Medical Inc..
[139110322]
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.
Patient Sequence No: 1, Text Type: N, H10
[139110323]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2019-00002 |
| MDR Report Key | 8423580 |
| Date Received | 2019-03-15 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES FITZGERALD |
| Manufacturer Street | 5900 FIRST AVE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| Manufacturer G1 | NATUS MEDICAL INC. |
| Manufacturer Street | 5900 FIRST AVE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NATUS BILIBAND EYE PROTECTOR |
| Generic Name | BILIBAND |
| Product Code | FOK |
| Date Received | 2019-03-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 5900 FIRST AVE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-15 |