MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-19 for THD REVOLUTION 700017 manufactured by Thd America.
[50215675]
Patient was having a transanal hemorrhoidal dearterialization using the thd revolution and following the surgery was noted to have 6 small, superficial burns in the area surrounding the anus. These corresponded to where the light from the device was positioned during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063546 |
| MDR Report Key | 5811694 |
| Date Received | 2016-07-19 |
| Date of Report | 2016-06-29 |
| Date of Event | 2016-06-20 |
| Date Added to Maude | 2016-07-21 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | THD REVOLUTION |
| Generic Name | THD REVOLUTION |
| Product Code | JAF |
| Date Received | 2016-07-19 |
| Model Number | 700017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THD AMERICA |
| Manufacturer Address | 9 TECH CIRCLE STE 103 NATICK MA 01760 US 01760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-19 |