POD PACKING COIL Adverse Event — Malfunction (MDR 3005168196-2020-00597)
POD PACKING COIL Adverse Event — Malfunction (MDR 3005168196-2020-00597) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POD PACKING COIL; Generic name: HCG, KRD; Manufacturer: PENUMBRA, INC..
| Device | POD PACKING COIL |
|---|---|
| Generic name | HCG, KRD |
| Manufacturer | PENUMBRA, INC. |
| Report number | 3005168196-2020-00597 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →