MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-12 for TRUSCULPT manufactured by Cutera, Inc.
[49317667]
Clinic has not returned the handpiece.
Patient Sequence No: 1, Text Type: N, H10
[49317668]
On june 17, 2016, (b)(6) reported to cutera that the patient developed a linear burn on the anterior neck (over the thyroid cartilage) while receiving a trusculpt treatment to the submentum area with the 40 cm trusculpt handpiece. (b)(6) sent photos of the anterior neck that showed an injury consistent with a thermal injury to the skin. (b)(6) reported that there are no malfunctions or failures associated with the trusculpt handpiece and they will not return the handpiece to cutera at this time. On june 23, 2016 (b)(6) retracted the report and stated the patient did not develop a burn from the trusculpt treatment but did not offer an alternative explanation for the injury. Burns are a known and expected side effect listed in the trusculpt instructions for use. The burn on the neck is not a life threatening injury or a serious deterioration in the patient's health but it does require professional medical management. The wound is in a cosmetically sensitive area and is high risk for scarring. This is the basis for reporting the incident to the fda. The clinic stopped responding to cutera's request for information about the event and has reported that the patient is "doing fine". The root cause of the incident is abnormal use by the device operator. Treating over the thyroid cartilage or trachea is foreseeable misuse. The trusculpt instructions for use and clinical training clearly advise the device operator that treatment of skin over the thyroid cartilage or trachea is contraindicated. The clinic reported that there are no malfunctions of failures associated with the trusculpt handpiece. Cutera has recommended that the device operator review all the clinical training and instructions for use for the submentum treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954354-2016-00002 |
| MDR Report Key | 5787228 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-12 |
| Date of Report | 2016-06-17 |
| Date of Event | 2016-05-31 |
| Date Mfgr Received | 2016-06-17 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2016-07-12 |
| 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 | MS RENEE LIERLY |
| Manufacturer Street | 3240 BAYSHORE BLVD |
| Manufacturer City | BRISBANE CA 94005 |
| Manufacturer Country | US |
| Manufacturer Postal | 94005 |
| Manufacturer Phone | 4156575731 |
| Manufacturer G1 | CUTERA, INC |
| Manufacturer Street | 3240 BAYSHORE BOULEVARD |
| Manufacturer City | BRISBANE CA 94005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUSCULPT |
| Generic Name | RADIO FREQUENCY INDUCED HEAT |
| Product Code | PBX |
| Date Received | 2016-07-12 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CUTERA, INC |
| Manufacturer Address | 3240 BAYSHORE BLVD BRISBANE CA 94005 US 94005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-12 |