MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-09-03 for PANOSOL 3D UVB-631 manufactured by National Biological Corp..
[25153947]
Na.
Patient Sequence No: 1, Text Type: N, H10
[25153948]
During first in home treatment, the patient followed her physician's recommended treatment time of 10 minutes front of body and 10 minutes back of body. The patient experienced burning and blistering the day after treatment. The patient contacted her physician and followed-up with an appointment in which the physician reiterated the original recommended treatment time. The patient was prescribed a cream and steroids for the burns. Nbc spoke with the prescribing physician who admitted to not consulting the manual but instead used a verbally recommended protocol from his staff. Phototherapy is not performed at the facility, and the physician has not performed phototherapy treatment in recent years. Nbc strongly believes that the patient experienced an injury due to a lack of training on the physician's and staff's part.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1521608-2015-00004 |
| MDR Report Key | 5060307 |
| Report Source | CONSUMER |
| Date Received | 2015-09-03 |
| Date of Report | 2015-08-20 |
| Date of Event | 2015-07-17 |
| Date Mfgr Received | 2015-07-22 |
| Device Manufacturer Date | 2015-04-14 |
| Date Added to Maude | 2015-09-08 |
| 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 Street | 23700 MERCANTILE RD. |
| Manufacturer City | BEACHWOOD OH 44122 |
| Manufacturer Country | US |
| Manufacturer Postal | 44122 |
| Manufacturer Phone | 2168310600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PANOSOL 3D |
| Generic Name | PHOTOTHERAPY UNIT |
| Product Code | FTC |
| Date Received | 2015-09-03 |
| Model Number | UVB-631 |
| Catalog Number | UVB-631 |
| Lot Number | 9907 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL BIOLOGICAL CORP. |
| Manufacturer Address | 23700 MERCANTILE RD., BEACHWOOD OH 44122 US 44122 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-03 |