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.
[125655485]
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
[125655486]
A doctor reported a patient underwent abdominal liposuction treatment on (b)(6) 2018. There was no immediate adverse event during the post-op period. Patient returned for follow-up on (b)(6) 2018 and the doctor noted areas of significant burns. The doctor reported that 1st, 2nd, and a quarter-sized 3rd degree burn are was seen in the lower abdomen and abdominal flank. A photo provided by the doctor shows a burn and crust from left to right flank and abdomen. Patient was treated with creams, ointments and antibiotics. Doctor reports that on subsequent visits, there were more areas of 3rd degree burns. Patient was referred to a plastic surgeon where a debridement and secondary closure was done. Doctor indicated patient is recovering and permanent scarring may or may not occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00106 |
| MDR Report Key | 8024207 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-09-11 |
| 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 |