PUREWICK FEMALE EXTERNAL Adverse Event — Malfunction (MDR 1018233-2020-02863)
PUREWICK FEMALE EXTERNAL Adverse Event — Malfunction (MDR 1018233-2020-02863) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PUREWICK FEMALE EXTERNAL; Generic name: PUREWICK; Manufacturer: C.R. BARD, INC. (COVINGTON) -1018233.
| Device | PUREWICK FEMALE EXTERNAL |
|---|---|
| Generic name | PUREWICK |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Report number | 1018233-2020-02863 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | CONSUMER, DISTRIBUTOR, OTHER |
| Narrative | THE REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO THE MATERIAL SURFACE WAS ROUGH ABRASIVE OR UNCOMFORTABLE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS UNKNOWN AND THE INFORMATION ON THE PACKAGING LOT NUMBER WAS NOT AVAILABLE THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INS |
| Source | openFDA MAUDE (device adverse events) |
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