MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-05 for RELIEVA ULTIRRA SINUS BALLOON CATHETER WITH THE RELIEVA SIDEKICK BC0716RU manufactured by Acclarent, Inc..
| Report Number | MW5089617 |
| MDR Report Key | 8970949 |
| Date Received | 2019-09-05 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-08-29 |
| Date Added to Maude | 2019-09-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RELIEVA ULTIRRA SINUS BALLOON CATHETER WITH THE RELIEVA SIDEKICK |
| Generic Name | INSTRUMENT, ENT MANUAL SURGICAL |
| Product Code | LRC |
| Date Received | 2019-09-05 |
| Catalog Number | BC0716RU |
| Lot Number | 181029B-PC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-05 |