MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-08 for PIFA HEPARIN/PF4 RAPID ASSAY 4036025 manufactured by Akers Biosciences, Inc..
| Report Number | 2247413-2019-00002 |
| MDR Report Key | 9166299 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-08 |
| Date Mfgr Received | 2019-06-12 |
| Device Manufacturer Date | 2018-03-22 |
| Date Added to Maude | 2019-10-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JENNIFER LELINSKI |
| Manufacturer Street | 201 GROVE RD |
| Manufacturer City | THOROFARE NJ 08086 |
| Manufacturer Country | US |
| Manufacturer Postal | 08086 |
| Manufacturer Phone | 8568488698 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIFA HEPARIN/PF4 RAPID ASSAY |
| Generic Name | PIFA HEPARIN/PF4 RAPID ASSAY |
| Product Code | LCO |
| Date Received | 2019-10-08 |
| Catalog Number | 4036025 |
| Lot Number | 24298 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AKERS BIOSCIENCES, INC. |
| Manufacturer Address | 201 GROVE ROAD THOROFARE NJ 08086 US 08086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2019-10-08 |