MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for VARADY DOUBLE ENDED FB-1 manufactured by Wagner Medical.
[135002019]
During an ambulatory phlebectomy, the end of the varady fb 1 (phlebectomy) hook broke off inside of the patient's right upper thigh. Using ultrasound guidance, the doctor was able to retrieve the broken piece after about 15 minutes of manipulation. The broken instrument was saved and will be returned to the manufacturer for failure analysis. Manufacturer response for surgical instrument, varady hook, varady double ended (per site reporter). The device will be returned for failure analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8304388 |
| MDR Report Key | 8304388 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-01-21 |
| Date of Event | 2019-01-08 |
| Report Date | 2019-01-21 |
| Date Reported to FDA | 2019-01-21 |
| Date Reported to Mfgr | 2019-02-05 |
| Date Added to Maude | 2019-02-05 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | VARADY DOUBLE ENDED |
| Generic Name | STRIPPER, VEIN, REUSABLE |
| Product Code | GAI |
| Date Received | 2019-02-05 |
| Model Number | FB-1 |
| Catalog Number | FB-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAGNER MEDICAL |
| Manufacturer Address | 202 DODD ST. MIDDLEBOURNE WV 26149 US 26149 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-05 |