MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-01-07 for 1.5T LINX, 14B LXMC14 manufactured by Torax Medical, Inc..
| Report Number | 3008766073-2020-00003 |
| MDR Report Key | 9558713 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-01-07 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2015-06-15 |
| Date Added to Maude | 2020-01-07 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 4188 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN |
| Manufacturer Phone | 6107428552 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2038-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.5T LINX, 14B |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-07 |
| Returned To Mfg | 2020-02-10 |
| Model Number | LXMC14 |
| Catalog Number | LXMC14 |
| Lot Number | 8413 |
| Device Expiration Date | 2019-06-15 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAX MEDICAL, INC. |
| Manufacturer Address | 4188 LEXINGTON AVENUE NORTH SHOREVIEW MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |