MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-15 for COLOR SLIDE II manufactured by Seradyn, Inc..
[5838]
In 4/94, we began noticing an increase in positive monospot tests using device. At that time, the co was notified and several samples and the kit in use were sent to them. Their technical svc rep agreed that these results were false positives. Since then we have been checking all positives by another method and have found several more false positives. Co has not given rptr a resonable explanation at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002848 |
| MDR Report Key | 14727 |
| Date Received | 1994-07-15 |
| Date of Report | 1994-07-01 |
| Date of Event | 1994-04-01 |
| Date Added to Maude | 1994-07-18 |
| 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 | COLOR SLIDE II |
| Generic Name | COLOR SLIDE |
| Product Code | LJN |
| Date Received | 1994-07-15 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14721 |
| Manufacturer | SERADYN, INC. |
| Manufacturer Address | INDIANAPOLIS IN 46206 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-07-15 |