MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for EDWARDS PERICARDIAL PATCH 4700 manufactured by Edwards Lifesciences.
[136891058]
The device was not returned to edwards for evaluation. In this case, the packaging of a patch was damaged in transit to hospital. A definitive root cause could not be determined at this time. Edwards lifesciences will continue to monitor all reported events. No further actions are required at this time.
Patient Sequence No: 1, Text Type: N, H10
[136891059]
As reported, the packaging of a patch was damaged in transit to hospital. As reported, the box was squashed, internal container cracked and bovine pericardial patch was poking through cracked container.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-00516 |
| MDR Report Key | 8345158 |
| Date Received | 2019-02-15 |
| Date of Report | 2019-01-25 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-03-01 |
| Device Manufacturer Date | 2018-07-08 |
| Date Added to Maude | 2019-02-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 MLE2 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502289 |
| 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 | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Product Code | DXZ |
| Date Received | 2019-02-15 |
| Returned To Mfg | 2019-02-19 |
| Model Number | 4700 |
| Catalog Number | 4700 |
| Lot Number | 61406763 |
| 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 | 1 EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |