ERGOPLANT ORAL SILICONE WEDGE #M Adverse Event — Malfunction (MDR 9610612-2020-00152)
ERGOPLANT ORAL SILICONE WEDGE #M Adverse Event — Malfunction (MDR 9610612-2020-00152) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ERGOPLANT ORAL SILICONE WEDGE #M; Generic name: DENTAL; Manufacturer: AESCULAP AG.
| Device | ERGOPLANT ORAL SILICONE WEDGE #M |
|---|---|
| Generic name | DENTAL |
| Manufacturer | AESCULAP AG |
| Report number | 9610612-2020-00152 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | UPDATED INVESTIGATION: PSC ADDED. INVESTIGATION RESULTS: THERE ARE DISCOLORATIONS AND RESIDUES REMAINED AT THE TRANSITION BETWEEN METAL PART AND SILICONE. VISUAL INVESTIGATION: UNDER MICROSCOPIC ENLARGEMENT IT CAN BE SEEN THAT THE METAL PART IS COVERED WITH A THIN TRANSPARENT SILICON LAYER. THIS LAYER SHOWS SEVERAL DAMAGES (TEARS). SEVERAL RESIDUES/CONTAMINATIONS HAVE BEEN DEPOSITED IN THIS AREA. |
| Source | openFDA MAUDE (device adverse events) |
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