MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-11-25 for VANQUISH manufactured by Btl Industries Limited.
[32127408]
Btl followed up with the patient to gather additional information. Per the patient burns, lumps and pain had resolved by eight weeks. Btl is not successful to gather additional information from the user facility. Btl will continue with the investigation. 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
[32127409]
A voluntary report (mw5056629) was filed with the agency by patient. A female patient treated by vanquish to abdomen experienced burns, three lumps and pain in the treated area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005028741-2015-00006 |
| MDR Report Key | 5250188 |
| Report Source | OTHER |
| Date Received | 2015-11-25 |
| Date of Report | 2015-11-25 |
| Date of Event | 2015-09-08 |
| Date Mfgr Received | 2015-10-26 |
| Device Manufacturer Date | 2013-11-29 |
| Date Added to Maude | 2015-11-25 |
| 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 |
| 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 | 2015-11-25 |
| 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 | 2015-11-25 |
| 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 | 2015-11-25 |