MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-22 for THERMAGE TIP MC-TIP-RP-4S manufactured by Solta Medical, Inc..
[112004144]
The tip was received and visually inspected. The tip did have burn marks on the sides of the treatment tip, however we are unable to determine what caused the burn marks. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[112004145]
At the beginning of a fraxel treatment to the face a spark emitted from the tip. The patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00061 |
| MDR Report Key | 7628983 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-22 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-05-30 |
| Date Added to Maude | 2018-06-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 11720 N CREEK PARKWAY N STE 10 |
| Manufacturer City | BOTHELL WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal | 98011 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | BAUSCH + LOMB, INC. |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63122 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMAGE TIP |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM |
| Product Code | ONG |
| Date Received | 2018-06-22 |
| Returned To Mfg | 2018-06-06 |
| Model Number | MC-TIP-RP-4S |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL, INC. |
| Manufacturer Address | 11720 NORTH CREEK PKWY N SUITE BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-22 |