MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2000-07-12 for SHELHIGH PERICARDIAL PATCH NRSHP555 manufactured by Shelhigh, Inc..
[182978]
Mediastinitis post-open heart surgery. The shelhigh pericardial patches were used to cover the heart after surgery. The mediastinitis occurred in 3 hosps (42 cases) out of 140 hospitals that have used the shelhigh pericardial patch. The patch was removed in a few cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247123-2000-00001 |
| MDR Report Key | 286013 |
| Report Source | 01,08 |
| Date Received | 2000-07-12 |
| Date of Report | 2000-07-11 |
| Date Facility Aware | 1999-10-26 |
| Report Date | 2000-07-11 |
| Date Added to Maude | 2000-07-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 67-71 E WILLOW ST |
| Manufacturer City | MILLBURN NJ 07041 |
| Manufacturer Country | US |
| Manufacturer Postal | 07041 |
| Manufacturer Phone | 9734677861 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHELHIGH PERICARDIAL PATCH |
| Generic Name | BOVINE PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 2000-07-12 |
| Returned To Mfg | 1999-12-01 |
| Model Number | NRSHP555 |
| Catalog Number | NRSHP555 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 276766 |
| Manufacturer | SHELHIGH, INC. |
| Manufacturer Address | 67-71 EAST WILLOW STREET MILLBURN NJ 07041 US |
| Baseline Brand Name | SHELHIGH PERICARDIAL PATCH |
| Baseline Generic Name | BOVINE PERICARDIAL PATCH |
| Baseline Model No | NRSHP555 |
| Baseline Catalog No | NRSHP555 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2000-07-12 |