MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-04 for TRUSCULPT manufactured by Cutera, Inc.
[81894635]
Partial thickness burn with slow wound healing. The wound is in a cosmetically sensitive area. The slow wound healing increases the risk for scar formation. The root cause of the burn is user error. The device operator treated over a contraindicated area. There is not a device performance complaint associated with the clinical event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954354-2017-00002 |
| MDR Report Key | 6769344 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-04 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-07-19 |
| Device Manufacturer Date | 2017-03-06 |
| Date Added to Maude | 2017-08-04 |
| 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 | MRS RENEE LIERLY, R.N. |
| 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 BLVD |
| Manufacturer City | BRISBANE CA 94005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUSCULPT |
| Generic Name | RADIO FREQUENCY INDUCED HEATING |
| Product Code | PBX |
| Date Received | 2017-08-04 |
| 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. Other | 2017-08-04 |