MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-01 for QED QED SCATTER 11300-2 * manufactured by Sun Nuclear Corporation.
[2652392]
9upon removal of dosing diodes from patient's skin, a blister were noted at the site of one of the diodes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2564685 |
| MDR Report Key | 2564685 |
| Date Received | 2012-05-01 |
| Date of Report | 2012-02-20 |
| Date of Event | 2011-09-29 |
| Report Date | 2012-02-20 |
| Date Reported to FDA | 2012-05-01 |
| Date Added to Maude | 2012-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QED |
| Generic Name | DOSIMETER, RADIATION, DIODE DETECTOR |
| Product Code | LHO |
| Date Received | 2012-05-01 |
| Model Number | QED SCATTER 11300-2 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUN NUCLEAR CORPORATION |
| Manufacturer Address | 425-A PINEDA COURT MELBOURNE FL 32940 US 32940 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-01 |