SPECTRA 12MMX16CM Adverse Event — Malfunction (MDR 10000374)
SPECTRA 12MMX16CM Adverse Event — Malfunction (MDR 10000374) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SPECTRA 12MMX16CM; Generic name: PROSTHESIS, PENILE; Manufacturer: AMERICAN MEDICAL SYSTEMS, INC..
| Device | SPECTRA 12MMX16CM |
|---|---|
| Generic name | PROSTHESIS, PENILE |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Report number | 10000374 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | PRIOR TO PLACEMENT, COATING ON THE METAL IMPLANT RIPPED AND METAL WAS EXPOSED. |
| Source | openFDA MAUDE (device adverse events) |
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