MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-01 for ENGINEERED BICUSPID HEART VALVE manufactured by Cryolife.
[5775325]
Experimental surgeries. Parents not informed. (b)(6), seizures unstoppable. Break out of (b)(6) so bad in her mouth (b)(6) 2007; mouth could not close because what looked like a bunch of blood clots. We were never informed of these diseases. Engineered valve first of its kind by cryolife inc. Tissue implanted at (b)(6) by dr (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042437 |
| MDR Report Key | 4744824 |
| Date Received | 2015-05-01 |
| Date of Event | 2005-12-01 |
| Date Added to Maude | 2015-05-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENGINEERED BICUSPID HEART VALVE |
| Generic Name | CRYOLIFE INC (GEORGIA) |
| Product Code | OHA |
| Date Received | 2015-05-01 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Death; 3. Hospitalization; 4. Life Threatening; 5. Other; 6. Required No Informationntervention; 7. Deathisabilit | 2015-05-01 |