MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for TRUSCULPT ID manufactured by Cutera, Inc.
[146650771]
The device operator report "error codes" during the procedure. The handpiece has returned to the manufacturer for compressive testing. A follow up report will submitted after the analysis is complete.
Patient Sequence No: 1, Text Type: N, H10
[146650772]
2 linear blisters on the treatment area (abdomen). The handpiece associated with the treatment has been returned to cutera for comprehensive testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954354-2019-00001 |
| MDR Report Key | 8538173 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-03-21 |
| Date Mfgr Received | 2019-03-26 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2019-04-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS RENEE LIERLY |
| Manufacturer Street | 3240 BAYSHORE BLVD |
| Manufacturer City | BRISBANE CA 94005 |
| Manufacturer Country | US |
| Manufacturer Postal | 94005 |
| Manufacturer Phone | 4156575731 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRUSCULPT ID |
| Generic Name | MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT |
| Product Code | PBX |
| Date Received | 2019-04-22 |
| Returned To Mfg | 2019-04-05 |
| Model Number | TRUSCULPT ID |
| 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. Other | 2019-04-22 |