MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-31 for VASERLIPO SYSTEM 110-0032 manufactured by Bausch + Lomb.
[125653071]
The product was returned and evaluated. The reported problem could not be duplicated. Testing was completed without any issue; no problems were found. A review of the device history records is in progress. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[125653072]
A doctor reported a patient underwent abdominal liposuction treatment on (b)(6) 2018. The treatment was described as uneventful. The patient returned to the office on (b)(6) 2018 and had some bruises which was expected. Patient returned on (b)(6) 2018 for a scheduled lymphatic massage and mentioned to the doctor she may be having an allergic reaction to the tape that was used for dressing. The doctor examined the area and observed skin peeling. At that point, it wasn? T immediately apparent to the doctor that the patient had burns. The patient returned on (b)(6) 2018 and it was then apparent that the patient sustained mostly 2nd degree and some 1st degree burns on the stomach area. A photo provided by the doctor showed visible skin burn, crust and scarring. Patient was treated with nitro bid creams, antibiotics cream, xerofoam and aloe burn cream. The doctor managed the patient conservatively and the majority of her burn areas have improved and are still healing. There is a quarter size area that appears to be a 3rd degree burn that the doctor is still managing conservatively. Patient has some skin scarring and modularity at the burn sites; there may be permanent scarring that will need future cosmetic care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00105 |
| MDR Report Key | 8024181 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-09-10 |
| Device Manufacturer Date | 2018-04-13 |
| Date Added to Maude | 2018-10-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD |
| Manufacturer City | SAINT LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 636-226-31 |
| Manufacturer G1 | SOLTA MEDICAL, INC. |
| Manufacturer Street | 11720 N CREEK PARKWAY N STE 100 |
| 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 | VASERLIPO SYSTEM |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2018-10-31 |
| Returned To Mfg | 2018-10-09 |
| Model Number | 110-0032 |
| Catalog Number | 110-0032 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-31 |