MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2011-09-07 for NATUS BILIBAND REGULAR SIZE PN 900642 manufactured by Olympic Medical Incorporated.
[17407405]
Infant being treated with phototherapy somehow removed the label from the natus biliband eye protector; the label was found by nicu personnel in the infant's hand. No injury occurred. However, there was the potential of a choking hazard.
Patient Sequence No: 1, Text Type: D, B5
[17817665]
Although the device that was the subject of this complaint was not available for eval, natus medical evaluated product from the same lot ((b)(4)) as well as product from a lot built before ((b)(4)) and a lot built after ((b)(4)) after the suspect lot. In all cases, the labels were adhered to the bilibands. Pull tests were performed on these labels. None of the labels tested were removed without a reasonable amount of force. (b)(4) has distributed bilibands for eight years. Since this is the first report of an infant removing the label during use and since the issue could not be duplicated with testing, (b)(4) believes this is an isolated incident. Other than submitting this mdr, no further action is advocated at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2011-00005 |
| MDR Report Key | 2267858 |
| Report Source | 01,05,08 |
| Date Received | 2011-09-07 |
| Date of Report | 2011-09-07 |
| Date of Event | 2011-08-11 |
| Date Mfgr Received | 2011-08-11 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2012-06-25 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 5900 FIRST AVE., SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685170 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATUS BILIBAND |
| Generic Name | NEONATAL EYE PAD |
| Product Code | FOK |
| Date Received | 2011-09-07 |
| Model Number | REGULAR SIZE |
| Catalog Number | PN 900642 |
| Lot Number | F11101210R |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPIC MEDICAL INCORPORATED |
| Manufacturer Address | SEATTLE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-07 |