MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-08-05 for TRUSCULPT manufactured by Cutera, Inc..
[4085424]
Pt experienced a burn in the area that the procedure was performed. The device was returned to the mfr, evaluated and found to have damage to the patient contact surface of the rf electrode. The damage is consistent with mechanical scraping and compression to the patient contact surface. The damage to the surface of the electrode is visible and easily detectable by the device operator by visual inspection. The burn healed with residual "small divot".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954354-2013-00016 |
| MDR Report Key | 3481482 |
| Report Source | 99 |
| Date Received | 2013-08-05 |
| Date of Report | 2013-07-09 |
| Date of Event | 2013-06-14 |
| Date Mfgr Received | 2013-07-09 |
| Device Manufacturer Date | 2013-05-26 |
| Date Added to Maude | 2013-11-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUSCULPT |
| Generic Name | MASAGER, VACUUM, RADIO FREQUENCTY INDUCED HEAT, |
| Product Code | PBX |
| Date Received | 2013-08-05 |
| Returned To Mfg | 2013-07-18 |
| Model Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-08-05 |