MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-10-07 for MODULITH SLX-F2 180MM (19K) LITHOTRIPTOR 19000F2 manufactured by Storz Medical Ag.
| Report Number | 9613347-2019-00095 |
| MDR Report Key | 9163309 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-10-07 |
| Date of Report | 2019-10-01 |
| Date of Event | 2019-09-25 |
| Date Mfgr Received | 2019-10-01 |
| Device Manufacturer Date | 2012-11-20 |
| Date Added to Maude | 2019-10-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | STORZ MEDICAL AG |
| Manufacturer Street | UNTERESEESTRASSE 47 |
| Manufacturer City | KREUZLINGEN CH-8280, |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODULITH SLX-F2 180MM (19K) LITHOTRIPTOR |
| Generic Name | LITHOTRIPTOR |
| Product Code | LNS |
| Date Received | 2019-10-07 |
| Model Number | 19000F2 |
| Catalog Number | 19000F2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STORZ MEDICAL AG |
| Manufacturer Address | UNTERESEESTRASSE 47 KREUZLINGEN CH-8280, SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-07 |