MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-12 for CERAFIX DURA SUBSTITUTE C1-3X3 manufactured by Acera Surgical, Inc.
| Report Number | 3012429393-2019-00001 |
| MDR Report Key | 9702081 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2018-11-29 |
| Date Added to Maude | 2020-02-12 |
| 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. JOSHUA TUCKER |
| Manufacturer Street | 7842 HICKORY FLAT HWY STE. B |
| Manufacturer City | WOODSTOCK, GA |
| Manufacturer Country | US |
| Manufacturer Phone | 8372681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERAFIX DURA SUBSTITUTE |
| Generic Name | CERAFIX |
| Product Code | GXQ |
| Date Received | 2020-02-12 |
| Model Number | C1-3X3 |
| Lot Number | 27749 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACERA SURGICAL, INC |
| Manufacturer Address | 7842 HICKORY FLAT HWY STE. B WOODSTOCK, GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |