MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-24 for VERION DIGITAL MARKER M X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).
| Report Number | 3010300699-2020-00001 |
| MDR Report Key | 9748363 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-24 |
| 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. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW 14513 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14513 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERION DIGITAL MARKER M |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2020-02-24 |
| Model Number | X-SPM |
| Catalog Number | 8065998244 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH (AGPS) |
| Manufacturer Address | RHEINSTRASSE 8 TELTOW 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-24 |