MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-27 for RADSURE * manufactured by Isp Technologies, Inc..
[85233]
1) radiation-oncology department tests each lot of radsure indicators before blood bank puts them to use. 2) the procedure involves irradiating the indicators using a 6mv linear accelerator x-ray beam at doses of 5,10,15 & 20 gy's. 3) the indicators are then observed for the appropriate color change to verify that the expected amount of radiation has occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013565 |
| MDR Report Key | 163699 |
| Date Received | 1998-03-27 |
| Date Added to Maude | 1998-04-23 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | RADSURE |
| Generic Name | 25 GY IRRADIATION INDICATOR |
| Product Code | MOT |
| Date Received | 1998-03-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | G57A11U25 |
| ID Number | * |
| Device Expiration Date | 1999-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 159341 |
| Manufacturer | ISP TECHNOLOGIES, INC. |
| Manufacturer Address | 1361 ALPS RD WAYNE NJ 07470 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-03-27 |