UNKNOWN SALINE IMPLANTS Adverse Event — Injury (MDR 1645337-2020-05919)
UNKNOWN SALINE IMPLANTS Adverse Event — Injury (MDR 1645337-2020-05919) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNKNOWN SALINE IMPLANTS; Generic name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE; Manufacturer: MENTOR TEXAS.
| Device | UNKNOWN SALINE IMPLANTS |
|---|---|
| Generic name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Manufacturer | MENTOR TEXAS |
| Report number | 1645337-2020-05919 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | DEVICE EVALUATION SUMMARY: DURING A VISUAL EVALUATION, AN AREA OF MISSING MATERIAL WAS OBSERVED IN THE ANTERIOR VIEW, MEASURING APPROXIMATELY 1.2 CM X 1.9 CM. MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE DEFLATION COULD NOT BE IDENTIFIED. CAUSES OF DEFLATION OF SALINE IMPLANTS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: CREASE FOLD FAILURE, INTRAOPERATIVE OR POSTOPERATIVE TR |
| Source | openFDA MAUDE (device adverse events) |
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