MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1998-05-01 for PERICARDIAL PATCH - 5 CM X 12 CM 710 HP710 manufactured by Medtronic Heart Valves, Inc..
[95651]
Health care professional reported pericardial patch was abandoned due to white material floating in the jar. The patch was never used for implant purposes - no pt consequences were reported. The product was returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-1998-00018 |
| MDR Report Key | 166232 |
| Report Source | 05,07 |
| Date Received | 1998-05-01 |
| Date of Report | 1998-04-01 |
| Date of Event | 1998-04-01 |
| Date Facility Aware | 1998-04-01 |
| Report Date | 1998-04-01 |
| Date Reported to Mfgr | 1998-04-01 |
| Date Mfgr Received | 1998-04-01 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 1998-05-08 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERICARDIAL PATCH - 5 CM X 12 CM |
| Generic Name | BOVINE PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 1998-05-01 |
| Returned To Mfg | 1998-04-03 |
| Model Number | 710 |
| Catalog Number | HP710 |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 1999-10-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DAY |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 161776 |
| Manufacturer | MEDTRONIC HEART VALVES, INC. |
| Manufacturer Address | 18011 SOUTH MITCHELL IRVINE CA 92614 US |
| Baseline Brand Name | HANCOCK PERICARDIAL PATCH |
| Baseline Generic Name | PERICARDIAL PATCH |
| Baseline Model No | 710 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Baseline Device Family | PATCHES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K830883 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-01 |