MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-27 for NATUS BILIBAND EYE PROTECTOR 900642, 900643 manufactured by Natus Medical Incorporated.
[71105172]
There is a "caution" in the biliband instructions for use that instruct the user to "avoid obstructing the nose and check regularly that this does not occur. " the instructions also include a diagram and instructions explaining proper positioning and fastening of the biliband. Review of complaint record determined there has been no customer report on the bilibands getting into infant's mouths in the past five years. This investigation is ongoing and additional information has been requested from the user facility. Samples from user facility requested.
Patient Sequence No: 1, Text Type: N, H10
[71105173]
Natus received a customer complaint indicating that "three incidents where infants were able to get the bilibands into their mouths, almost choking. " investigation of the events concluded that improperly secured bilibands or improper sizing of the biliband causing a loose fit or overstretched product are the likely causes of the reported events.
Patient Sequence No: 1, Text Type: D, B5
[73920313]
There is a "caution" in the biliband instructions for use that instruct the user to "avoid obstructing the nose and check regularly that this does not occur. " the instructions also include a diagram and instructions explaining proper positioning and fastening of the biliband. The customer provided natus a picture, which displays improper use of the biliband device. Investigation of these events has concluded that either improperly secured bilibands or improper sizing of the biliband causing a loose fit or overstretched product are the causes of the reported events. Review of complaint records determined there has been no customer report on the bilibands getting into infant's mouths in the past five years. The end user has been provided instructional documentation and training on the use of the biliband device after these reported events. Please note that additional information, such as patient information or date of event, were requested from the customer. This report is considered final and this investigation is concluded. Customer communication.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2017-00243 |
| MDR Report Key | 6434977 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-27 |
| Date of Report | 2017-02-24 |
| Date Mfgr Received | 2017-02-24 |
| Date Added to Maude | 2017-03-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEFFREY MANTKOWSKI |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685143 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATUS BILIBAND EYE PROTECTOR |
| Generic Name | BILIBAND |
| Product Code | FOK |
| Date Received | 2017-03-27 |
| Model Number | 900642, 900643 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-27 |