MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-02-12 for VANQUISH manufactured by Btl Industries Limited.
[19457808]
Btl industries followed up with the physician's office to gather additional information. Per the physician's office patient reported hot spots during the treatment. And also, patient reports that she did try to "tough it out" even when the treatment was getting a little too hot. Per the information provided by physician office, the procedure on (b)(6) 2013 was conducted with no malfunctions. Btl industries reviewed the system logs for the treatment date and confirmed that no system malfunction occurred. 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
[19485353]
Reported that a female patient treated by vanquish complained of burns and blisters in the treated area. No signs of injury immediately after the treatment. The following day injury appeared. Patient was seen by doctor and was prescribed topical burn cream silvadene and antibiotic doryx - 125 mg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005028741-2014-00001 |
| MDR Report Key | 3641112 |
| Report Source | 06 |
| Date Received | 2014-02-12 |
| Date of Report | 2014-02-03 |
| Date of Event | 2013-12-31 |
| Date Mfgr Received | 2014-01-13 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 47 LORING DR |
| Manufacturer City | FRAMINGHAM MA 01702 |
| Manufacturer Country | US |
| Manufacturer Postal | 01702 |
| Manufacturer Phone | 8662851656 |
| Manufacturer G1 | BTL INDUSTRIES LTD |
| Manufacturer Street | 30 PESHTERSKO SHOUSE BLVD |
| Manufacturer City | PLOVDIV 4002 |
| Manufacturer Country | BU |
| Manufacturer Postal Code | 4002 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANQUISH |
| Product Code | IMJ |
| Date Received | 2014-02-12 |
| Operator | HEALTH PROFESSIONAL |
| 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 SHOUS BLVD PLOVDIV 4002 BU 4002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-12 |