RESTORE PRIME ADVANCED Adverse Event — Injury (MDR 3004209178-2008-00690)
RESTORE PRIME ADVANCED Adverse Event — Injury (MDR 3004209178-2008-00690) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RESTORE PRIME ADVANCED; Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.; Report number: 3004209178-2008-00690.
| Device | RESTORE PRIME ADVANCED |
|---|---|
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Report number | 3004209178-2008-00690 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-15 |
| Report source | Company representation |
| Narrative | THE REPRESENTATIVE REPORTED THE PATIENT HAD EXPERIENCED SYMPTOMS OF REDNESS AND SCABBING AT THE INS IMPLANT SITE. THE PATIENT HAD DEVELOPED AN INFECTION; THE CAUSATIVE ORGANISM WAS UNKNOWN. THE PRODUCT WAS EXPLANTED AND RETURNED FOR ANALYSIS. THE PATIENT WAS RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN. |
| Source | openFDA MAUDE (device adverse events) |
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