MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-17 for TITAN XL manufactured by Cutera, Inc..
[15778195]
"four - five small blisters after titan treatment".
Patient Sequence No: 1, Text Type: D, B5
[15871586]
The user facility initially reported that the area was "healing well" and did not require intervention. (b)(6) 2012, user facility reported that pt required medical intervention.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954354-2012-00008 |
| MDR Report Key | 2470740 |
| Report Source | 05,06 |
| Date Received | 2012-02-17 |
| Date of Report | 2012-02-21 |
| Date of Event | 2011-12-01 |
| Date Mfgr Received | 2012-01-06 |
| Device Manufacturer Date | 2010-06-17 |
| Date Added to Maude | 2012-07-31 |
| 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 |
| 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 | ILY OPTIONAL INFRARED HANDPIECE |
| Product Code | ILY |
| Date Received | 2012-02-17 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | BRISBANE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-02-17 |