MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-11 for THD S. P. A. - VIA INDUSTRIA manufactured by Thd America, Inc..
[52311254]
After transanal hemorrhoidal dearterialization (thd) procedure utilizing the revolution thd machine, the surgeon noticed 2 blisters on the right side of the pt's rectum and 2 blisters on the left side of the rectum. The new revolution (va. Evolution) thd equipment can only he used with the light cord touching the pt's skin. The thd rep revealed the company was aware there was a risk to pt's skin as a similar event had occurred at another hospital in the area. Per the rep, a couple mds (not all were contacted to inform them of this risk, but not the hospital, allowing this subsequent event to occur. A new hand piece is being sent to replace the existing version.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064099 |
| MDR Report Key | 5878317 |
| Date Received | 2016-08-11 |
| Date of Report | 2016-08-11 |
| Date of Event | 2016-08-08 |
| Date Added to Maude | 2016-08-16 |
| 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 |
| 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 S. P. A. - VIA INDUSTRIA |
| Generic Name | THD REVOLUTION |
| Product Code | JAF |
| Date Received | 2016-08-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THD AMERICA, INC. |
| Manufacturer Address | 9 TECH CIRCLE, STE 103 NATICK MA 01760 US 01760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-11 |