MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-10 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[178959402]
Pc (b)(4). Date sent: 01/10/2020. The lot was not provided; therefore, the manufacturing record evaluation could not be performed. The following information was requested, but unavailable: do you have the linx product code (model number), lot number and serial number (if applicable)? Were there any intra-operative complications during implant? Was there any hiatal or crural repair done at the same time as the implant? Do you have an autoimmune disease? Are you currently taking steroids / immunization drugs? When you have your appointment with your physician, please let us know what, if any, next steps will be taken to address the symptoms you are having. Please let us know when you have any diagnostic testing done to address the symptoms you are experiencing.
Patient Sequence No: 1, Text Type: N, H10
[178959403]
It was reported a linx device was implanted on (b)(6) twenty nineteen. Since that time, he has had pain, bloating, gas, and trouble swallowing. The patient thinks that the device was placed to high up above the sphincter. Physician had prescribed carafate suspension and omeprazole to address the abdominal pain that he is experiencing. The patient has an appointment scheduled with is physician to discuss the removal of the device and he will call back with any new information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00009 |
| MDR Report Key | 9575287 |
| Report Source | CONSUMER |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-09-04 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-10 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 4188 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN |
| Manufacturer Phone | 6107428552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK LINX MAGNETIC IMPLANT |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-10 |
| Catalog Number | UNK LINX MAGNETIC IMPLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-10 |