MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-13 for TRUSCULPT manufactured by Cutera, Inc..
[3242056]
Burn.
Patient Sequence No: 1, Text Type: D, B5
[10289483]
The actual device was evaluated; the root cause was loss of dielectric contact due to the film lifting.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954354-2012-00015 |
| MDR Report Key | 2872552 |
| Report Source | 07 |
| Date Received | 2012-06-13 |
| Date of Report | 2012-06-13 |
| Date of Event | 2012-05-25 |
| Date Mfgr Received | 2012-05-25 |
| Date Added to Maude | 2012-12-14 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS RENEE LIERLY |
| Manufacturer Street | 3240 BAYSHORE BLVD |
| Manufacturer City | BRISBANE CA 94005 |
| Manufacturer Country | US |
| Manufacturer Postal | 94005 |
| Manufacturer Phone | 4153575731 |
| 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 | CUTERA CMMCD |
| Product Code | NUV |
| Date Received | 2012-06-13 |
| Returned To Mfg | 2012-05-25 |
| Model Number | NA |
| Catalog Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2012-06-13 |