MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for EDWARDS PERICARDIAL PATCH 4700 manufactured by Edwards Lifesciences.
[142185480]
Evaluation summary: as received, the tamper seal of the shelf box was broken and the patch jar was missing the shrink wrap seal. No damage was found to patch jar and jar still contained patch and glutaraldehyde solution. Tagalert was not returned. Any packaging non-conformance that results in a breach of the sterile package (i. E. Pinhole, tear or seal issue), has the potential to result in a serious infection. Per the product evaluation, the customer report of that "plastic cover around the top of a pericardial patch was broken" was confirmed. An engineering task has been opened and assigned for further investigation. A supplemental report will be submitted upon completion. The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution. No issues were identified that would have impacted this event. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
[142185481]
Edwards received information that the plastic cover around the top of a pericardial patch jar was broken prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01281 |
| MDR Report Key | 8509965 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-03-19 |
| Date Mfgr Received | 2019-06-19 |
| Device Manufacturer Date | 2019-01-03 |
| Date Added to Maude | 2019-04-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMRITHA SRINIVASAN |
| Manufacturer Street | 1 EDWARDS WAY MLE-2 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492504062 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EDWARDS PERICARDIAL PATCH |
| Generic Name | INTRACARDIAC PATCH |
| Product Code | DXZ |
| Date Received | 2019-04-12 |
| Returned To Mfg | 2019-04-02 |
| Model Number | 4700 |
| Catalog Number | 4700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |