MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-21 for VYSIS LSI PML/RARA DUAL COLOR/DUAL FUSION PROBES 05J70-01 manufactured by Abbott Molecular, Inc..
| Report Number | 3005248192-2019-00005 |
| MDR Report Key | 8724041 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-06-21 |
| Date of Report | 2019-07-01 |
| Date of Event | 2019-06-07 |
| Date Mfgr Received | 2019-06-21 |
| Device Manufacturer Date | 2019-02-02 |
| Date Added to Maude | 2019-06-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOE HUTSON |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617619 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VYSIS LSI PML/RARA DUAL COLOR/DUAL FUSION PROBES |
| Generic Name | REAGENTS, SPECIFIC, ANALYTE |
| Product Code | MVU |
| Date Received | 2019-06-21 |
| Catalog Number | 05J70-01 |
| Lot Number | 492875 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-21 |