MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 1997-07-25 for EDWARDS PERICARDIAL PATCH 4700 NA manufactured by Baxter Healthcare Corp. Edwards Cvs Division.
[18159842]
This event was reported as dehiscence and infection. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000002-1997-00629 |
| MDR Report Key | 108052 |
| Report Source | 02 |
| Date Received | 1997-07-25 |
| Date of Report | 1997-06-26 |
| Date of Event | 1997-05-06 |
| Date Mfgr Received | 1997-06-26 |
| Device Manufacturer Date | 1996-12-01 |
| Date Added to Maude | 1997-07-29 |
| 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 | EDWARDS PERICARDIAL PATCH |
| Generic Name | PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 1997-07-25 |
| Model Number | 4700 |
| Catalog Number | NA |
| Lot Number | 6L1297 |
| ID Number | NA |
| Device Expiration Date | 2000-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 106195 |
| Manufacturer | BAXTER HEALTHCARE CORP. EDWARDS CVS DIVISION |
| Manufacturer Address | 17221 RED HILL AVENUE IRVINE CA 92614 US |
| Baseline Brand Name | EDWARDS PERICARDIAL PATCH |
| Baseline Generic Name | NA |
| Baseline Model No | 4700 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | PERICARDIAL PATCH |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K833763 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-07-25 |