MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-13 for SGPH00 manufactured by Cryolife, Inc..
[1488329]
According to the report, blood cultures of the recipient taken some time after implant developed results positive for gram - negative rods.
Patient Sequence No: 1, Text Type: D, B5
[8652048]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report. Synergraft pulmonary hemi-artery is regulated by the fda as a device and therefore this report is being submitted to (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063481-2010-00014 |
| MDR Report Key | 1691568 |
| Report Source | 05 |
| Date Received | 2010-05-13 |
| Date of Report | 2010-05-13 |
| Date of Event | 2010-04-19 |
| Date Mfgr Received | 2010-04-19 |
| Device Manufacturer Date | 2009-10-03 |
| Date Added to Maude | 2011-04-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRYAN BROSSEAU, MANAGER |
| Manufacturer Street | 1655 ROBERTS BLVD., N.W. |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | OHA |
| Date Received | 2010-05-13 |
| Model Number | SGPH00 |
| ID Number | 103929 (DONOR) |
| Device Expiration Date | 2010-10-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | KENNESAW GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-13 |