MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-01-11 for TRUSCULPT manufactured by Cutera, Inc..
[3689106]
Coating failure of treatment surface on handpiece. Device operator used the device to test on another person - not a patient. The coating failure caused a small burn that has healed without medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[10963055]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954354-2013-00002 |
| MDR Report Key | 3245089 |
| Report Source | 06,07 |
| Date Received | 2013-01-11 |
| Date of Report | 2012-12-14 |
| Date of Event | 2012-12-14 |
| Date Mfgr Received | 2012-12-14 |
| Date Added to Maude | 2013-07-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUSCULPT |
| Product Code | PBX |
| Date Received | 2013-01-11 |
| Returned To Mfg | 2012-12-17 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2013-01-11 |