MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-25 for VANQUISH manufactured by Btl Industries Limited.
[4332844]
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 md and was instructed on wound management and to cover wound with aquaphor and neosporin.
Patient Sequence No: 1, Text Type: D, B5
[11564790]
Btl industries followed up with the physician's office to gather additional information. Per the physician's office, patient reported few hot spots during the treatment. User responded by moving applicator away and/or decreasing energy. At the end of the treatment some moisture was felt on the patient's skin. Patient had no complaints of pain or itching in the area. Patient saw a burn specialist and was prescribed antibiotic cream and antibiotic wrap. Specialist said that the patient has 1 second degree burn and 1 third degree burn, making this a reportable event. Based on physician's office information, burns are healing. Per the physician's office, the procedure on (b)(6) 2014 was conducted successfully with no malfunction. Btl industries reviewed the system logs for the treatment date and confirmed that no system malfunction occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005028741-2014-00002 |
| MDR Report Key | 3716154 |
| Report Source | 06 |
| Date Received | 2014-03-25 |
| Date of Report | 2014-03-21 |
| Date of Event | 2014-02-17 |
| Date Mfgr Received | 2014-02-24 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-04-02 |
| 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 LIMITED |
| 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 | 2014-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-03-25 |