MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-08-19 for TITAN XL manufactured by Cutera.
[2177843]
September 22, 2010: cutera was notified by telephone by the treatment provider with report of a "blister in middle of forehead that left a deep scar. " the date of treatment was unknown. The treatment provider stated the treatment was in the "spring of 2009. " the treatment provider was unable to provide the following information: treatment date, patient information, treatment information or adverse event information. It is unknown if the patient and adverse event was evaluated.
Patient Sequence No: 1, Text Type: D, B5
[9295233]
February 29, 2008, titan xl handpiece (b)(4) sold. October 3, 2008: (b)(6) fse repair, repair complete case #(b)(4) preventive maintenance (handpiece operating within specification). February 26, 2009: (b)(6) fse repair, repair complete usd case #(b)(4) courtesy visit (handpiece operating within specification). Spring 2009 - treatment date. (b)(6) 2009: out of shots, sent for refill/end of life expectancy. Closed rma (b)(4) - administrative non-complaint (b)(4) titan refill. There were no other report of adverse events reported from this account. The handpiece was evaluated twice for preventive maintenance and found to be operating within specification. The handpiece was used to its full life expectancy with no other report of adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954354-2011-00015 |
| MDR Report Key | 2249626 |
| Report Source | 06 |
| Date Received | 2011-08-19 |
| Date of Report | 2011-08-19 |
| Date of Event | 2009-06-01 |
| Date Mfgr Received | 2010-09-22 |
| Device Manufacturer Date | 2007-06-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RENEE LIERLY, RN |
| Manufacturer Street | 3240 BAYSHORE BLVD |
| Manufacturer City | BRISBANE CA 94005 |
| Manufacturer Country | US |
| Manufacturer Postal | 94005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TITAN XL |
| Generic Name | TITAN XL |
| Product Code | ILY |
| Date Received | 2011-08-19 |
| Returned To Mfg | 2010-01-05 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CUTERA |
| Manufacturer Address | BRISBANE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-08-19 |