MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-24 for TRUSCULPT manufactured by Cutera, Inc..
[4046081]
The patient received a trusculpt procedure to the submental area. The device operator inadvertently included part of the anterior, middle area of the neck in the procedure. The patient reported developing a small lister on the anterior of the neck. The patient did not notify the physician to report the blister until after the area had already healed (approximately 1 month after the date of the procedure). The patient presented with a residual divot in the surface of the skin on the anterior neck the patient managed the wound care of the blister. The device was used to perform procedures on other patients both before and after this patient with no report of adverse events or side events or side effects. The device performed as intended.
Patient Sequence No: 1, Text Type: D, B5
[11331413]
The patient did not report the adverse event until 1 month after the date of the procedure. The device was used during the month after the event to perform procedures on other patients with no report of side effects or adverse events. The device was not returned to cutera. The device performed as intended as reported by the device operator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954354-2013-00020 |
| MDR Report Key | 3501542 |
| Report Source | 05,06 |
| Date Received | 2013-09-24 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-07-25 |
| Date Mfgr Received | 2013-08-27 |
| Device Manufacturer Date | 2012-12-12 |
| Date Added to Maude | 2013-12-06 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MS RENEE LIERLY, RN |
| Manufacturer Street | 3240 BAYSHORE BLVD |
| Manufacturer City | BRISBANE CA 94005 |
| Manufacturer Country | US |
| Manufacturer Postal | 94005 |
| Manufacturer Phone | 4156575700 |
| Manufacturer G1 | CUTERA, INC. |
| Manufacturer Street | 3240 BAYSHORE BLVD |
| 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 | MASSAGER, VACCUM, RADIO FREQUENCY INDUCED HEAT, |
| Product Code | PBX |
| Date Received | 2013-09-24 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | N |
| Device Age | DA |
| 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. Deathisabilit | 2013-09-24 |