MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-07 for PANOSOL 3D UVB-631 manufactured by National Biological Corp..
[33277105]
The doctor's office reported that the patient confirmed that he treated himself without reading the operations manual, and did not adhere to the treatment guidelines set forth by his doctor. Per the instruction manual and the guidelines of the physician, the maximum treatment exposure should not have exceeded 2 minutes and 13 seconds. The doctor's office confirmed that the patient treated for 10 minutes on both the front of his body and another 10 minutes on the back of his body. Nbc requested access to the device to conduct an evaluation; however, the request for access was denied. The device had just been delivered to the patient, so nbc reviewed the dhr and test records for the device and was able to confirm that the device was function as intended 76 days before the event. The doctor's office and nbc strongly believe that the patient injury was clearly a result of misuse of instructions for use as it pertains to treatment protocol.
Patient Sequence No: 1, Text Type: N, H10
[33277106]
National biological corporation received a call from a doctor's office regarding a patient injury. The patient was using panosol 3d system, model; uvb-631 and was burned. The exact location and degree of burns are not known at this time, but the doctor's office did inform nbc that the patient was treated in the icu. Current status of the patient was not available at the time of this report, but nbc was able to confirm that the patient was released home during a follow-up call with the doctor's office, ((b)(6) 2015).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1521608-2015-00005 |
| MDR Report Key | 5284950 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-07 |
| Date of Report | 2015-12-01 |
| Date of Event | 2015-11-05 |
| Date Mfgr Received | 2015-11-05 |
| Device Manufacturer Date | 2015-08-21 |
| Date Added to Maude | 2015-12-10 |
| 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 | LYNN KELLER |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PANOSOL 3D |
| Product Code | FTC |
| Date Received | 2015-12-07 |
| Model Number | UVB-631 |
| Catalog Number | UVB-631 |
| Lot Number | 10005 |
| ID Number | NA |
| 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 | 2015-12-07 |