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 II UVB-604 manufactured by National Biological Corporation.
[25072768]
Na.
Patient Sequence No: 1, Text Type: N, H10
[25072769]
Customer service received a complaint via voice-mail. When the call was returned the customer said he had purchased a piece of equipment at an auction and was inquiring about the manufacture date and purpose of the equipment as he had received 3rd degree burns after using it. When he was told it was a medical device and asked additional questions, the customer ended the call. No information other than the unit serial number was able to be gathered. Additional attempts to contact the customer were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1521608-2015-00003 |
| MDR Report Key | 5058094 |
| Report Source | CONSUMER |
| Date Received | 2015-09-03 |
| Date of Report | 2015-08-20 |
| Date of Event | 2015-07-20 |
| Date Mfgr Received | 2015-07-20 |
| Device Manufacturer Date | 1997-09-29 |
| Date Added to Maude | 2015-09-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PANOSOL II |
| Generic Name | PHOTOTHERAPY UNIT |
| Product Code | FTC |
| Date Received | 2015-09-03 |
| Model Number | UVB-604 |
| Catalog Number | UVB-604 |
| Lot Number | 1388 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL BIOLOGICAL CORPORATION |
| Manufacturer Address | 23700 MERCANTILE RD. BEACHWOOD OH 44122 US 44122 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-03 |