MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for TRIVEX SYSTEM manufactured by Lemaitre Vascular, Inc..
[180861625]
Left side of trivex stopped working when md went to use it for procedure on patient. Trivex device was set up prior to case and passed all initial checks. Tumescence was connected to left side of trivex device for transilluminated phlebectomy left lower leg. Md tested machine to use and a noise was heard, and pump stopped. Md assessed situation and everything changed to right side of machine and proceeded without difficulty. No injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9752969 |
| MDR Report Key | 9752969 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-21 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-02-26 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIVEX SYSTEM |
| Generic Name | STRIPPER, VEIN, EXTERNAL |
| Product Code | DWQ |
| Date Received | 2020-02-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |