MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-28 for SPECTRA UV THERAPY BOOTH 305/350 manufactured by Daavlin Co..
[9318]
Unit failed to terminate at preset time and milijoules according to pt treatment plan. Pt reported machine was getting hot and thought he'd been in there too long. Meter read 8:11 minutes but still 190 milijoules left. Physician examined pt and no apparent symptoms at that time. During investigation it was found that the unit had an fda recall in 1991, for the same problem. That was 2 yrs before rptr purchased unit. It appears the mfr sold rptr a unit that wasn't in fda compliance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002622 |
| MDR Report Key | 14371 |
| Date Received | 1994-06-28 |
| Date of Report | 1994-06-17 |
| Date of Event | 1994-04-11 |
| Date Added to Maude | 1994-06-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRA UV THERAPY BOOTH |
| Generic Name | UV THERAPY BOOTH |
| Product Code | FTC |
| Date Received | 1994-06-28 |
| Model Number | 305/350 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14367 |
| Manufacturer | DAAVLIN CO. |
| Manufacturer Address | BRYAN OH 435060626 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-06-28 |