MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-18 for SHOCKPULSE LITHOTRIPSY GENERATOR SPL-1 manufactured by Cybersonics Inc.
| Report Number | 8802636 |
| MDR Report Key | 8802636 |
| Date Received | 2019-07-18 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-06-26 |
| Report Date | 2019-07-03 |
| Date Reported to FDA | 2019-07-03 |
| Date Reported to Mfgr | 2019-07-18 |
| Date Added to Maude | 2019-07-18 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | SHOCKPULSE LITHOTRIPSY GENERATOR |
| Generic Name | LITHOTRIPTOR, ULTRASONIC |
| Product Code | FEO |
| Date Received | 2019-07-18 |
| Model Number | SPL-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERSONICS INC |
| Manufacturer Address | KNOWLEDGE PARK 5340 FRYLING ROAD, SUITE 101 ERIE PA 16510 US 16510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-18 |