MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06,07 report with the FDA on 2013-08-20 for TRUSCULPT manufactured by Cutera, Inc..
[18919724]
Patient developed 3 small linear burns (approximately 5mm - 8mm in length) after the procedure. Patient required prescription topical medication.
Patient Sequence No: 1, Text Type: D, B5
[19098645]
Device is scheduled to return to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954354-2013-00017 |
| MDR Report Key | 3840665 |
| Report Source | 04,06,07 |
| Date Received | 2013-08-20 |
| Date of Report | 2013-08-13 |
| Date of Event | 2013-08-12 |
| Date Mfgr Received | 2013-08-12 |
| Device Manufacturer Date | 2013-07-31 |
| Date Added to Maude | 2014-06-03 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MS. RENEE LIERLY, RN |
| 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 | MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT |
| Product Code | PBX |
| Date Received | 2013-08-20 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CUTERA, INC. |
| Manufacturer Address | 18 ENDEAVOR SUITE 307 IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-20 |