MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-30 for ONX MITRAL STANDARD 27/29 ONXM-27/29 manufactured by Cryolife, Inc. ? Austin.
[185551996]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report. This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event. Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
Patient Sequence No: 1, Text Type: N, H10
[185551997]
According to initial reports, patient received onxm-27/29 sn (b)(4) (b)(6) 2020. Patient deceased (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649833-2020-00007 |
| MDR Report Key | 9898457 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-02 |
| Date Facility Aware | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-30 |
| 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 | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1300 E. ANDERSON LN., BLDG. B |
| Manufacturer City | AUSTIN TX 78752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONX MITRAL STANDARD 27/29 |
| Generic Name | HEART-VALVE, MECHANICAL |
| Product Code | LWQ |
| Date Received | 2020-03-30 |
| Model Number | ONXM-27/29 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? AUSTIN |
| Manufacturer Address | 1300 E. ANDERSON LN., BLDG. B AUSTIN TX 78752 US 78752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-30 |