MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-16 for PICCOLO METLYTE 8 PANEL 400-0023 manufactured by Abaxis, Inc..
| Report Number | 2939693-2019-00001 |
| MDR Report Key | 9072470 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-09-16 |
| Date of Report | 2019-09-12 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2018-04-18 |
| Device Manufacturer Date | 2017-11-06 |
| Date Added to Maude | 2019-09-16 |
| 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 | MS. RONI THEBO |
| Manufacturer Street | 3240 WHIPPLE RD |
| Manufacturer City | UNION CITY CA 94587 |
| Manufacturer Country | US |
| Manufacturer Postal | 94587 |
| Manufacturer Phone | 2693599544 |
| Manufacturer G1 | ABAXIS, INC. |
| Manufacturer Street | 3240 WHIPPLE ROAD |
| Manufacturer City | UNION CITY CA 94587 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PICCOLO METLYTE 8 PANEL |
| Generic Name | PICCOLO METLYTE 8 |
| Product Code | CEM |
| Date Received | 2019-09-16 |
| Model Number | 400-0023 |
| Catalog Number | 400-0023 |
| Lot Number | 7461DB8 |
| Device Expiration Date | 2018-11-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABAXIS, INC. |
| Manufacturer Address | 3240 WHIPPLE ROAD UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-16 |