COMPLY Adverse Event — Malfunction (MDR 10000519)
COMPLY Adverse Event — Malfunction (MDR 10000519) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COMPLY; Generic name: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS; Manufacturer: 3M.
| Device | COMPLY |
|---|---|
| Generic name | INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS |
| Manufacturer | 3M |
| Report number | 10000519 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | WE HAVE A POTENTIAL SAFETY ISSUE REGARDING THE PRODUCTS USED IN HYDROGEN PEROXIDE STERILIZATION . 3M AND AESCULAP MAKE PRODUCTS FOR THE HYDROGEN PEROXIDE STERILIZATION AND THEY ARE OPPOSITE IN THE COLORS DESIGNATING PROCESSED AND UNPROCESSED. NEITHER COMPANY MAKES ALL THE PRODUCTS. 3 M MAKES THE PRODUCTS USED FOR WRAPPED ITEMS; GO FROM BLUE (UNPROCESSED/UNSTERILIZED) TO PINK (PROCESSED/STERILIZED) |
| Source | openFDA MAUDE (device adverse events) |
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