MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-25 for SHELHIGH, INC. PERICARDIAL PATCH manufactured by Shelhigh, Inc..
[810276]
Pt had a shelhigh, inc. , pericardial patch implanted in 2007 to augment the right ventricular outflow tract. Shelhigh's patch had to be removed about 6 weeks later, and was replaced with another type of graft material. Pt subsequently died 4 days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005977 |
| MDR Report Key | 1018945 |
| Date Received | 2008-03-25 |
| Date of Report | 2008-03-18 |
| Date of Event | 2007-01-26 |
| Date Added to Maude | 2008-03-27 |
| 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 | 3 |
| Reporter Occupation | ATTORNEY |
| 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 | SHELHIGH, INC. PERICARDIAL PATCH |
| Generic Name | PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 2008-03-25 |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 986052 |
| Manufacturer | SHELHIGH, INC. |
| Manufacturer Address | FANWOOD NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-03-25 |