MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-20 for SAVI manufactured by Cianna Medical Company.
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(b)(4) from cianna medical company called our pathology department requesting a reflector tumor marker that was removed from a patient. The company rep i spoke with said that the product failed and they want to examine it. Company rep said the reflector system gets deactivated when touched with a bovie.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073437 |
| MDR Report Key | 7048343 |
| Date Received | 2017-11-20 |
| Date of Report | 2017-11-16 |
| Date of Event | 2017-09-12 |
| Date Added to Maude | 2017-11-21 |
| 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 |
| 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 |
| Generic Name | SCOUT REFLECTOR DEVICE |
| Product Code | PBY |
| Date Received | 2017-11-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIANNA MEDICAL COMPANY |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-20 |