MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-10-09 for VANQUISH manufactured by Btl Industries Limited.
[28029312]
Btl followed up with the user facility to gather additional information. Per the user facility patient tolerated the treatment well. The patient? S injury is still healing. The system logs were reviewed for the treatment date and confirmed that no system malfunction occurred during the treatment date. A f/u report will be made to the agency if and when new information is received about this case.
Patient Sequence No: 1, Text Type: N, H10
[28029313]
It was reported that a female patient treated by vanquish to abdomen experienced blisters in the treated area. Patient underwent debridement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005028741-2015-00005 |
| MDR Report Key | 5140799 |
| Report Source | USER FACILITY |
| Date Received | 2015-10-09 |
| Date of Report | 2015-10-09 |
| Date of Event | 2015-08-18 |
| Date Mfgr Received | 2015-09-10 |
| Device Manufacturer Date | 2015-05-08 |
| Date Added to Maude | 2015-10-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAN ZARSKY |
| Manufacturer Street | 47 LORING DR |
| Manufacturer City | FRAMINGHAM MA 01702 |
| Manufacturer Country | US |
| Manufacturer Postal | 01702 |
| Manufacturer Phone | 8662851656 |
| Manufacturer G1 | BTL INDUSTRIES LIMITED |
| Manufacturer Street | 30 PESHTERSKO SHOUSE BLVD |
| Manufacturer City | PLOVDIV, 4002 |
| Manufacturer Country | BU |
| Manufacturer Postal Code | 4002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANQUISH |
| Product Code | GEI |
| Date Received | 2015-10-09 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BTL INDUSTRIES LIMITED |
| Manufacturer Address | 30 PESHTERSKO SHOUSE BLVD PLOVDIV, 4002 BU 4002 |
| Brand Name | VANQUISH |
| Generic Name | SHORTWAVE DIATHERMY |
| Product Code | IMJ |
| Date Received | 2015-10-09 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BTL INDUSTRIES LIMITED |
| Manufacturer Address | 30 PESHTERSKO SHOUSE BLVD PLOVDIV, 4002 BU 4002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-09 |