MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-11-29 for VANQUISH manufactured by Btl Industries Limited.
[4109926]
Reported that a female pt treated by vanquish complained after the treatment of erythema in the treated area. The skin at this time appeared otherwise healthy and intact. The following day pt called the office and reported she had been to the emergency dept due to burns that had appeared in the treatment area. Pt was prescribed topical burn cream silvadene and oral antibiotics. The physician's office has reached out to the pt several times to follow-up. The pt has not returned their calls.
Patient Sequence No: 1, Text Type: D, B5
[11328657]
Btl industries followed up with the physician's office to gather additional info. Per the physician's office the procedure on (b)(6) 2013 was conducted successfully with no malfunctions. 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 | 3005028741-2013-00002 |
| MDR Report Key | 3504164 |
| Report Source | 06 |
| Date Received | 2013-11-29 |
| Date of Report | 2013-11-28 |
| Date of Event | 2013-10-25 |
| Date Mfgr Received | 2013-10-30 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2013-12-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | 2013-11-29 |
| 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 | 2013-11-29 |