MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-30 for VANQUISH manufactured by Btl Industries Limited.
[56013484]
As per information received a burn mark appeared on the vanquish applicator. Btl made an effort to get the device back for evaluation. We have been so far unable to receive the device back for evaluation. Btl also made an effort to follow up with the physician? S office and to gather additional information about the event. However, btl was unable to complete additional information. Due to the lack of information and impossibility to evaluate the device btl is unable to determine whether a system malfunction occurred during the treatment. It has not been possible to established if the device was used in accordance with the operator? S manual. Burns are listed in the operator? S manual as a potential adverse effect. A f/u report will be made to the agency if and when new information is received about this case. Unable to receive the device back.
Patient Sequence No: 1, Text Type: N, H10
[56013485]
It was reported that a male patient treated by vanquish complained of burn in the treated area (right shoulder blade).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005028741-2016-00001 |
| MDR Report Key | 5989962 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-30 |
| Date of Report | 2016-09-30 |
| Date of Event | 2016-08-31 |
| Date Mfgr Received | 2016-09-01 |
| Device Manufacturer Date | 2014-08-29 |
| Date Added to Maude | 2016-09-30 |
| 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 | GEI |
| Date Received | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-09-30 |
| 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 | 2016-09-30 |