MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-28 for HOUVA 4 manufactured by National Biological Corp..
[5927616]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13337705]
During discussion with (b)(6) clinicians, it was found that the facility was not following nbc's recommended / published protocol (koo). The facility was advised to utilize only nbc recommended and published protocols, as outlined in the ifu, for safe and effective treatment. The facility was following all other nbc guidelines.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1521608-2015-00002 |
| MDR Report Key | 4805594 |
| Report Source | 06 |
| Date Received | 2015-05-28 |
| Date Mfgr Received | 2015-04-17 |
| Device Manufacturer Date | 2013-12-02 |
| Date Added to Maude | 2015-06-01 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 23700 MERCANTILE RD |
| Manufacturer City | BEACHWOOD OH 44122 |
| Manufacturer Country | US |
| Manufacturer Postal | 44122 |
| Manufacturer Phone | 2168310600 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUVA 4 |
| Generic Name | PHOTOTHERAPY UNIT |
| Product Code | KGL |
| Date Received | 2015-05-28 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL BIOLOGICAL CORP. |
| Manufacturer Address | 1532 ENTERPRISE PKWY. TWINSBURG OH 44087 US 44087 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-28 |