MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-05 for LITHOTRON LITHOTRIPTER manufactured by Healthtronics, Inc..
| Report Number | 3005655081-2019-00006 |
| MDR Report Key | 8964971 |
| Date Received | 2019-09-05 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-08-23 |
| Device Manufacturer Date | 1998-03-01 |
| Date Added to Maude | 2019-09-05 |
| 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 | MR. THOMAS LYCAN |
| Manufacturer Street | 9825 SPECTRUM DR. BLDG. 3 |
| Manufacturer City | AUSTIN TX 78717 |
| Manufacturer Country | US |
| Manufacturer Postal | 78717 |
| Manufacturer Phone | 8882526575 |
| Manufacturer G1 | HEALTHTRONICS, INC. |
| Manufacturer Street | 9825 SPECTRUM DR. BLDG. 3 |
| Manufacturer City | AUSTIN TX 78717 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78717 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LITHOTRON LITHOTRIPTER |
| Generic Name | LITHOTRIPTER, EXTRACORPOREAL SHOCK-WAVE, UROLOGICAL |
| Product Code | LNS |
| Date Received | 2019-09-05 |
| Model Number | LITHOTRON |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTHTRONICS, INC. |
| Manufacturer Address | 9825 SPECTRUM DR. BLDG. 3 AUSTIN TX 78717 US 78717 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-05 |