MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-24 for BLILBAND manufactured by Natus Medical Inc..
[17950241]
Newborn was found under phototherapy with biliband mask on without the protective eye pads under the straps of the mask. New bill mask obtained. Pediatric ophthalmologist felt f/u visit after d/c would suffice. Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by calling my number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034047 |
| MDR Report Key | 3599948 |
| Date Received | 2014-01-24 |
| Date of Report | 2014-01-13 |
| Date of Event | 2014-01-06 |
| Date Added to Maude | 2014-01-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLILBAND |
| Generic Name | NATUS BILIBAND |
| Product Code | FOK |
| Date Received | 2014-01-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 1501 INDUSTRIAL RD. SAN CARLOS CA 94070 US 94070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-24 |