GEL-ONE Adverse Event — Injury (MDR 9612392-2020-00005)
GEL-ONE Adverse Event — Injury (MDR 9612392-2020-00005) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: GEL-ONE; Generic name: ACID, HYALURONIC, INTRAARTICULAR; Manufacturer: SEIKAGAKU CORPORATION.
| Device | GEL-ONE |
|---|---|
| Generic name | ACID, HYALURONIC, INTRAARTICULAR |
| Manufacturer | SEIKAGAKU CORPORATION |
| Report number | 9612392-2020-00005 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | THIS IS A DEFINITIVE REPORT. THIS CASE IS RECEIVED BY SEIKAGAKU CORPORATION ON APRIL 6, 2020 FROM THE FDA AS MW5093733 DATED MARCH 30, 2020. NO FURTHER INFORMATION WILL BE EXPECTED, SINCE NO CONTACT INFORMATION IS AVAILABLE. ACCORDING TO THE RESULT OF INVESTIGATION, THERE WERE NO DEVIATIONS OR OUT-OF-SPECIFICATIONS FOUND IN THE MANUFACTURING PROCESS, THE IN-PROCESS TESTING, THE RELEASE TESTING, AN |
| Source | openFDA MAUDE (device adverse events) |
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