MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-08-18 for VANQUISH manufactured by Btl Industries Limited.
[23300756]
Btl industries followed up with the physician? S office to gather additional information. Based on information received no errors or device malfunction occurred during the treatment. The system logs were reviewed for the treatment date and confirmed that no system malfunction occurred during the treatment. Burns are listed in the operator? S manual as a potential adverse effect. The patient is treated by the wound care specialist. As of (b)(6) 2015 the injury is not getting better. 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
[23300757]
It was reported that a female patient treated by vanquish to lower back complained of burn in the treated area. Patient is treated for wound with burn cooling patches, bacitracin and ibuprofen. Patient was seen by urgent care hospital. She was diagnosed with 3rd degree burn. Patient was referred to wound care specialist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005028741-2015-00003 |
| MDR Report Key | 5010695 |
| Report Source | USER FACILITY |
| Date Received | 2015-08-18 |
| Date of Report | 2015-08-18 |
| Date of Event | 2015-07-17 |
| Date Mfgr Received | 2015-07-18 |
| Device Manufacturer Date | 2012-05-23 |
| Date Added to Maude | 2015-08-18 |
| 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 |
| Generic Name | SHORTWAVE DIATHERMY |
| Product Code | IMJ |
| Date Received | 2015-08-18 |
| 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 SHOUSE BLVD PLOVDIV, 4002 BU 4002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-18 |