MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for VILEX IMPLANT UNKNOWN manufactured by Vilex In Tennessee, Inc..
[93133803]
As of this date 11/10/2017, vilex has not received any additional information from the sales rep or the doctor regarding the malfunction of this implant.
Patient Sequence No: 1, Text Type: N, H10
[93133804]
Vilex contacted the sales rep by phone august 29th and 30th. Sales rep stated it was dr. (b)(6) who had a patient with an implant that has been implanted for about 2 years and the implant was now broken in the toe and had not been removed. Vilex emailed the sales rep again asking for an issue review form to be completed on august 30, 2017. On september 8, 2017 vilex asked sales rep to please give more information and complete the form. On september 8, 2017, sales rep submitted the form, containing very little information, reporting a lesser met hemi was broken. At the time of this report, this is all the known information that vilex has acquired. A supplemental report will be filed should vilex receive more information regarding this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051526-2017-00001 |
| MDR Report Key | 7034804 |
| Date Received | 2017-11-15 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-08-29 |
| Date Added to Maude | 2017-11-15 |
| 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 | SYLVIA SOUTHARD |
| Manufacturer Street | 111 MOFFITT STREET |
| Manufacturer City | MCMINNVILLE TN 37110 |
| Manufacturer Country | US |
| Manufacturer Postal | 37110 |
| Manufacturer Phone | 9314747550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VILEX IMPLANT |
| Generic Name | VILEX IMPLANT |
| Product Code | KWD |
| Date Received | 2017-11-15 |
| Model Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VILEX IN TENNESSEE, INC. |
| Manufacturer Address | 111 MOFFITT STREET MCMINNVILLE TN 37110 US 37110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-15 |