MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-28 for DAAVLIN SPECTRA, 311/350 821PH2424V6 manufactured by Daavlin Distributing Company.
[5189119]
A physician informed daavlin that a patient has initiated malpractice litigation against said physician for alleged burns following an accidental overdose. Per physician, and civil court filings, the patient alleges that symptoms of erythema have lasted longer than 7 days though the treating physician deny the severity of the symptoms. This incident took place during the patients first treatment. Internal office protocol indicates that 150mj of narrow band uvb treatment was prescribed for the first treatment, however, the operator delivered 1,500mj narrow band uvb treatment. The device associated with this report has been regularly serviced and calibrated, prior to and after the event in question, by daavlin authorized service technicians and has been determined to be in good working condition. The treating physicians agree and are all under the opinion that the overdose was strictly due to operator use error. In so much as the device contributed to the error, it was only by means of operator misuse/error.
Patient Sequence No: 1, Text Type: D, B5
[12772047]
A 1,500mj dose of narrow band uvb light would typically be reached within 3-4 weeks of narrow band uvb treatment of a fitzpatrick skin type ii patient. It is a dose that might be delivered to a treatment naive skin type ii patient as a part of photopatch testing, or directly to a psoriatic lesion with a targeted light source, but it would be expected to cause erythema in non-lesional skin. The device associated with this report has been regularly serviced and calibrated, prior to and after the event in question, by daavlin authorized service technicians and has been determined to be in good working condition. The conclusion is that this event is attributable to human factors issues where use error, the interaction between the device and user, directly caused the event. The treating physicians agree and are all of the opinion that the overdose was strictly due to operator use error. In so much as the device contributed to the event, it was only by means of operator use error/ misuse. There was no direct failure attributable to the device itself and it has been determined that the device operated within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526255-2015-00001 |
| MDR Report Key | 4471077 |
| Report Source | 06 |
| Date Received | 2015-01-28 |
| Date of Report | 2015-01-14 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2015-01-14 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2015-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. TIMOTHY LEHTONEN |
| Manufacturer Street | 205 WEST BEMENT STREET P.O. BOX 626 |
| Manufacturer City | BRYAN OH 43506 |
| Manufacturer Country | US |
| Manufacturer Postal | 43506 |
| Manufacturer Phone | 4196366304 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAAVLIN |
| Generic Name | SPECTRA, 311/350 |
| Product Code | FTC |
| Date Received | 2015-01-28 |
| Model Number | SPECTRA, 311/350 |
| Catalog Number | 821PH2424V6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAAVLIN DISTRIBUTING COMPANY |
| Manufacturer Address | BRYAN OH 43506 US 43506 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-01-28 |