CLINICAL GEL SLTX Adverse Event — Injury (MDR 1645337-2020-05912)
CLINICAL GEL SLTX Adverse Event — Injury (MDR 1645337-2020-05912) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CLINICAL GEL SLTX; Generic name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FI; Manufacturer: MENTOR TEXAS.
| Device | CLINICAL GEL SLTX |
|---|---|
| Generic name | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FI |
| Manufacturer | MENTOR TEXAS |
| Report number | 1645337-2020-05912 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | Consumer |
| Narrative | ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 29, 2020. THE PATIENT CLARIFIED THE CAUSE OF THE STROKE. A DOUBLE TOOTH EXTRACTION AND A POST SURGICAL INFECTION CAUSED THE STROKE. THE RUPTURE WAS DISCOVERED DURING TESTING FOR THIS UNRELATED ISSUE. H6 (PATIENT CODES) HAS BEEN UPDATED. ADDITIONALLY, H6 (CONCLUSION CODES) INITIALLY REPORTED CODE 4315 (CAUSE NOT ESTABLISHED). THIS CODE IS NO LONGER APPLI |
| Source | openFDA MAUDE (device adverse events) |
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