UNKNOWN ARCTICGEL PADS Adverse Event — Malfunction (MDR 1018233-2020-02890)
UNKNOWN ARCTICGEL PADS Adverse Event — Malfunction (MDR 1018233-2020-02890) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNKNOWN ARCTICGEL PADS; Generic name: GEL PAD; Manufacturer: MEDIVANCE, INC. ¿ 1725056.
| Device | UNKNOWN ARCTICGEL PADS |
|---|---|
| Generic name | GEL PAD |
| Manufacturer | MEDIVANCE, INC. ¿ 1725056 |
| Report number | 1018233-2020-02890 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, OTHER, USE |
| Narrative | THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE " INADEQUATE CHANNEL DESIGN." THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ALTHOUGH THE PRODUCT CODE IS UNKNOWN, THE Z300-UNKNOWN ARCTICGELS PADS PRODUCT LABELING IS FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. |
| Source | openFDA MAUDE (device adverse events) |
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