MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2013-07-02 for TRUSCULPT manufactured by Cutera, Inc..
[45526883]
Observations reported from end user: it was reported that two pts, both of who were both treated on the abdomen, had an adverse reactions to the trusculpt procedure while using hand piece (b)(4). The first pt injured by the device had an adverse reaction after 1 of 16 imprints used, whereas the second pt had a 4 distinct reactions (each from individual imprints) out of 32 imprints. Both pts failed to report any pain significantly greater than that experienced during an adverse event free imprint. Engineering observations: the hand piece was first initialized on a system, and the number of treatments remaining was noted. The hand piece had 35 treatments left before it was to be returned for maintenance, indicating that 13 treatments had been delivered prior to the onset of the adverse reactions noted here. Conclusion: while we cannot rule out a bare electrode or excessive perspiration; however, it is unlikely that these two mechanisms initiated electrode failure since the failure occurred subsequently on two different pts. Likely physical damage was the root cause of the failure because not only was the burn in the vicinity of the damage, but spatially coincident with it. Moreover, the burns started occurring after 13 previous treatments. Likely the electrode was damaged after the 13th treatment, but before the 14th. Sweat and partial contact may have exacerbated the film failure.
Patient Sequence No: 1, Text Type: N, H10
[45526884]
The pt developed small burns on the abdomen, one burn healed with residual scar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954354-2013-00010 |
| MDR Report Key | 5666164 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2013-07-02 |
| Date of Report | 2013-06-03 |
| Date of Event | 2013-05-31 |
| Date Mfgr Received | 2013-06-03 |
| Device Manufacturer Date | 2013-03-13 |
| Date Added to Maude | 2016-05-19 |
| 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 | 3 |
| 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 | 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 | 2013-07-02 |
| 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 | 1. Deathisabilit | 2013-07-02 |