MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-29 for TRUSCULPT TXH10009 manufactured by Cutera.
[16449838]
Device operator intended to perform a procedure in the submentum area. The device operator inadvertently included tissue of the upper, anterior neck in the procedure area. Electrode placement error. The patient developed a blister on the anterior of the neck. There were no adverse events in the submentum area. The patient did not report the blister to the user facility until 5 days after the procedure. The patient presented with approximately a 6mm wound with signs of localized infection (redness, drainage and swelling). The physician prescribed oral antibiotics. The wound was not cultured. Wound closed and healed; redness is slowly resolving without medical intervention. The device was not returned to cutera. The device has been used to perform procedures on other patients with no report of adverse events.
Patient Sequence No: 1, Text Type: D, B5
[16688918]
The device has not been returned to the mfr for evaluation. The device has been used to perform procedures on other patient's with no report of adverse events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954354-2013-00022 |
| MDR Report Key | 3547967 |
| Report Source | 06 |
| Date Received | 2013-10-29 |
| Date of Report | 2013-09-30 |
| Date of Event | 2013-09-25 |
| Date Mfgr Received | 2013-09-30 |
| Device Manufacturer Date | 2013-07-22 |
| Date Added to Maude | 2014-01-03 |
| 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 |
| 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 |
| 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 | 2013-10-29 |
| Model Number | NA |
| Catalog Number | TXH10009 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CUTERA |
| Manufacturer Address | 3240 BAYSHORE BLVD BRISBANE CA 94005 US 94005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-29 |