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 2011-09-22 for NATUS BILIBAND PREMATURE SIZE PN 900643 manufactured by Natus Medical Incorporated.
[19932888]
Customer reported to distribution partner that velcro grip did not hold for a natus biliband during treatment. There was no pt injury. Customer filed report with safety agency in (b)(4) alleging that loose velcro is a clinical risk.
Patient Sequence No: 1, Text Type: D, B5
[20273304]
Natus medical incorporated has distributed bilibands for eight years. Natus has not considered velcro adhesion complaints to be reportable. This mdr is being submitted because the hospital reporting this complaint also submitted a report to (b)(4) safety agency. Natus capa(b)(4) is open to track product improvements, including velcro adhesion, for the natus biliband.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2011-00006 |
| MDR Report Key | 2278982 |
| Report Source | 01,05,08 |
| Date Received | 2011-09-22 |
| Date of Report | 2011-09-22 |
| Date of Event | 2011-08-19 |
| Date Mfgr Received | 2011-08-24 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2012-06-27 |
| 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 | 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 | 2011-09-22 |
| Model Number | PREMATURE SIZE |
| Catalog Number | PN 900643 |
| Lot Number | F1109107P |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | SEATTLE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-22 |