MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-07-25 for LIPOSONIX SYSTEM MODEL 2 P005875 manufactured by Bausch + Lomb.
[80986696]
Patient Sequence No: 1, Text Type: N, H10
[80986697]
A report received from a user facility in (b)(6) stated that a patient who received liposonix treatment on (b)(6) 2017 on abdomen and flanks reported a 2nd degree burn with blisters on lower abdomen. One hour after the procedure the patient called the doctor complaining of pain and three hours later he called again complaining that 4-5 small blisters had appeared on the treated area. The doctor asked the patient to come back. Five hours post procedure, the blisters accumulated to 1 bigger blister. The blister was drained and treated with heal light laser ( red light) for faster wound healing. The patient was also prescribed oral antibiotic, hydrocolloid dressing for 7 days and prednisolone oral for 1 day. The pain is gone and the burn is resolving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2017-00043 |
| MDR Report Key | 6742103 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-07-25 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-25 |
| Date Mfgr Received | 2017-07-28 |
| Date Added to Maude | 2017-07-25 |
| 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 | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST.LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | SOLTA MEDICAL INC |
| Manufacturer Street | 11818 NORTH CREEK PARKWAY NORTH |
| Manufacturer City | BOTHELL WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSONIX SYSTEM MODEL 2 |
| Generic Name | FOCUSED ULTRASOUND FOR TISSUE HEAT OR CELLULAR DIS |
| Product Code | OHV |
| Date Received | 2017-07-25 |
| Returned To Mfg | 2017-07-27 |
| Model Number | P005875 |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-25 |