MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-02 for PULMONARY HEMI-ARTERY SG SGPH00 manufactured by Cryolife, Inc..
[15009530]
According to the report, the hosp stated that a pre-implant culture taken from the synergraft pulmonary hemi-artery tested positive for (b)(6) (species not reported). Additionally, the hosp reported that all pt blood cultures have come back negative, and there are no systemic signs or symptoms of infection.
Patient Sequence No: 1, Text Type: D, B5
[15522315]
This investigation is currently ongoing. Any add'l info 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 | 1063481-2010-00004 |
| MDR Report Key | 1622877 |
| Report Source | 05 |
| Date Received | 2010-03-02 |
| Date of Report | 2010-03-02 |
| Date Mfgr Received | 2010-02-09 |
| Date Added to Maude | 2011-04-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRYAN BROSSEAU, FIELD MGR |
| 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 |
| Brand Name | PULMONARY HEMI-ARTERY SG |
| Generic Name | NON-VALVED HEART ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2010-03-02 |
| Model Number | SGPH00 |
| ID Number | 103255 (DONOR #) |
| 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 | 2010-03-02 |