MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-19 for MODULITH SLX-F2 180MM (25K) LITHOTRIPTOR 25000 manufactured by Storz Medical Ag.
| Report Number | 9613347-2019-00109 |
| MDR Report Key | 9345162 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-19 |
| Date of Report | 2019-11-14 |
| Date of Event | 2019-11-08 |
| Date Mfgr Received | 2019-11-14 |
| Device Manufacturer Date | 2018-08-29 |
| Date Added to Maude | 2019-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 (25K) LITHOTRIPTOR |
| Generic Name | LITHOTRIPTOR |
| Product Code | LNS |
| Date Received | 2019-11-19 |
| Model Number | 25000 |
| Catalog Number | 25000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Death; 2. Other | 2019-11-19 |