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.
[125654866]
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
[125654868]
A doctor reported a patient underwent abdominal liposuction treatment on (b)(6) 2018. There was no apparent burn during the immediate post-op period. About two days later the doctor noticed the patient had sustained what seemed to be a first degree burn about 3x3 cm in size. A follow up was made three days later and the burn area had extended. It was also reported the patient had blisters. A photo provided by the doctor showed visible skin burn and crust. The doctor took steps to mitigate skin loss. Patient was treated with nitro b. I. D and silver oil. Patient was referred to wound care clinic and will need limited debridement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00107 |
| MDR Report Key | 8024217 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-09-27 |
| 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 |
| 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 |