MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-08-18 for TITAN XL manufactured by Cutera Brisbane.
[20918498]
"depression" on left cheek after titan treatment. There was not a preceding burn, blister or other injury in the affected area.
Patient Sequence No: 1, Text Type: D, B5
[21235439]
This adverse event occurred after treatment #3. Pt had received 2 prior treatments without incident. The 2 prior treatments were performed with a different titan handpiece. The titan handpiece had been reconditioned on (b)(6) 2011. The titan handpiece was sold on (b)(6) 2011. The treatment date was (b)(6) 2011, there were no burns, blisters or break in the integrity of the skin. The pt reported that approx 1-2 days after treatment, she noted a "depression on the left cheek". The depression has not resolved as of (b)(6) 2011, (b)(6) weeks post treatment. The titan handpiece was returned to cutera on (b)(4) 2011 and is being evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954354-2011-00014 |
| MDR Report Key | 2223817 |
| Report Source | 05,06,07 |
| Date Received | 2011-08-18 |
| Date of Report | 2011-08-18 |
| Date of Event | 2011-07-09 |
| Date Mfgr Received | 2011-07-12 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-06-26 |
| 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 | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RENEE LIERLY, RN, COORD |
| 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 | 3 |
| Brand Name | TITAN XL |
| Generic Name | TITAN |
| Product Code | ILY |
| Date Received | 2011-08-18 |
| Returned To Mfg | 2011-08-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CUTERA BRISBANE |
| Manufacturer Address | CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-18 |