MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-17 for THERASCREEN EGFR RGQ PCR KIT 1 870121 manufactured by Qiagen Gmbh.
| Report Number | 3004013603-2020-00001 |
| MDR Report Key | 9845343 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-08-08 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LINDSEY HOWARD |
| Manufacturer Street | 19300 GERMANTOWN RD. |
| Manufacturer City | GERMANTOWN, MD |
| Manufacturer Country | US |
| Manufacturer Phone | 6867826 |
| Manufacturer G1 | QIAGEN GMBH |
| Manufacturer Street | QIAGEN STRASSE 1 |
| Manufacturer City | HILDEN, NRW 40724 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 40724 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASCREEN EGFR RGQ PCR KIT |
| Generic Name | THERASCREEN EGFR RGQ PCR KIT |
| Product Code | OWD |
| Date Received | 2020-03-17 |
| Model Number | 1 |
| Catalog Number | 870121 |
| Lot Number | 163035334 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QIAGEN GMBH |
| Manufacturer Address | QIAGEN STRASSE 1 HILDEN, NRW 40724 GM 40724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-17 |