| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VASERLIPO SYSTEM | SYSTEM, SUCTION, LIPOPLASTY | BAUSCH + LOMB | MUU | 110-0032 | 110-0032 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-31 | 0 | 1. R |
Patient 1
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 1
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.