MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for SAVI APPLICATOR 8-2 manufactured by Cianna Medical.
[24233964]
Provider unable to remove savi applicator from patient. Patient transported to operating room for removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055748 |
| MDR Report Key | 5032624 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-08-18 |
| Date of Event | 2015-08-07 |
| Date Added to Maude | 2015-08-26 |
| 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 | SAVI APPLICATOR 8-2 |
| Generic Name | SAVI CATHETER |
| Product Code | JAQ |
| Date Received | 2015-08-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIANNA MEDICAL |
| Manufacturer Address | ALISO VIEJO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-20 |