MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-04 for SHOCKPULSE LITHOTRIPSY PROBE, SINGLE USE 3.40 MM (3/BOX) SPL-PDBX340 N/A manufactured by Cybersonics, Inc..
| Report Number | 3004216443-2019-00004 |
| MDR Report Key | 8667684 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-06-04 |
| Date of Report | 2019-06-04 |
| Date Mfgr Received | 2019-05-15 |
| Date Added to Maude | 2019-06-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS. WENDY BOND |
| Manufacturer Street | KNOWLEDGE PARK 5340 FRYLING RD, SUITE 101 |
| Manufacturer City | ERIE PA 165104703 |
| Manufacturer Country | US |
| Manufacturer Postal | 165104703 |
| Manufacturer Phone | 8148984734 |
| Manufacturer G1 | CYBERSONICS, INC. |
| Manufacturer Street | KNOWLEDGE PARK 5340 FRYLING RD, SUITE 101 |
| Manufacturer City | ERIE PA 165104703 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 165104703 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOCKPULSE LITHOTRIPSY PROBE, SINGLE USE 3.40 MM (3/BOX) |
| Generic Name | LITHOTRIPTOR, ULTRASONIC |
| Product Code | FEO |
| Date Received | 2019-06-04 |
| Model Number | SPL-PDBX340 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERSONICS, INC. |
| Manufacturer Address | KNOWLEDGE PARK 5340 FRYLING RD, SUITE 101 ERIE PA 165104703 US 165104703 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-04 |