SDS AMIIA GENESIS 5.0X18 142 Adverse Event — Malfunction (MDR 9616099-2020-03673)
SDS AMIIA GENESIS 5.0X18 142 Adverse Event — Malfunction (MDR 9616099-2020-03673) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SDS AMIIA GENESIS 5.0X18 142; Generic name: CATHETER, BILIARY, DIAGNOSTIC; Manufacturer: CORDIS CASHEL.
| Device | SDS AMIIA GENESIS 5.0X18 142 |
|---|---|
| Generic name | CATHETER, BILIARY, DIAGNOSTIC |
| Manufacturer | CORDIS CASHEL |
| Report number | 9616099-2020-03673 |
| Event type | Malfunction |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →