MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-21 for ID CORE XT 1020220034 manufactured by Progenika Biopharma S.a..
| Report Number | 3006413195-2020-00002 |
| MDR Report Key | 9740706 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-03-29 |
| Date Added to Maude | 2020-02-21 |
| 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 | DIEGO TEJEDOR |
| Manufacturer Street | IBAIZABAL BIDEA, EDIFICIO 504 PARQUE TECNOLOGICO DE BIZKAIA |
| Manufacturer City | DERIO, VIZCAYA 48160 |
| Manufacturer Country | SP |
| Manufacturer Postal | 48160 |
| Manufacturer G1 | PROGENIKA BIOPHARMA S.A. |
| Manufacturer Street | IBAIZABAL BIDEA, EDIFICIO 504 PARQUE TECNOLOGICO DE BIZKAIA |
| Manufacturer City | DERIO, 48160 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 48160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ID CORE XT |
| Generic Name | ID CORE XT |
| Product Code | PEP |
| Date Received | 2020-02-21 |
| Model Number | 1020220034 |
| Lot Number | 0203000018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROGENIKA BIOPHARMA S.A. |
| Manufacturer Address | IBAIZABAL BIDEA, EDIFICIO 504 PARQUE TECNOLOGICO DE BIZKAIA DERIO, 48160 SP 48160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |