MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-09-25 for CONTOUR NEXT manufactured by Ascensia Diabetes Care Us Inc..
| Report Number | 1810909-2019-00417 |
| MDR Report Key | 9118451 |
| Report Source | CONSUMER |
| Date Received | 2019-09-25 |
| Date of Report | 2019-08-28 |
| Date of Event | 2019-08-26 |
| Date Mfgr Received | 2019-10-30 |
| Device Manufacturer Date | 2019-01-01 |
| Date Added to Maude | 2019-09-25 |
| 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 | SHWETA GULATI |
| Manufacturer Street | 100 SUMMIT LAKE DRIVE |
| Manufacturer City | VALHALLA NY 10595 |
| Manufacturer Country | US |
| Manufacturer Postal | 10595 |
| Manufacturer Phone | 9142361830 |
| Manufacturer G1 | PHC CORPORATION (REGISTRATION NUMBER: 1000134386) |
| Manufacturer Street | 2131-1 MINAMIGATA 7 JACKSON RD. |
| Manufacturer City | TOON EHIME, MA 791-0395 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 791-0395 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOUR NEXT |
| Generic Name | QUALITY CONTROL MATERIAL |
| Product Code | JJX |
| Date Received | 2019-09-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSIA DIABETES CARE US INC. |
| Manufacturer Address | 100 SUMMIT LAKE DRIVE VALHALLA NY 10595 US 10595 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-25 |