Aveli AVE001Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00850036790006), received between Jun 29, 2022 and Aug 22, 2025 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AVELI PATIENT PRESENTED AT ONE MONTH POST TREATMENT WITH RESIDUAL FLUID RETENTION AT THE TREATMENT AREA. THE PATIENT FOLLOWED INSTRUCTIONS FROM THE PROVIDER. THE PROVIDER EVALUATED THE FLUID RETENTION ON ULTRASOUND. THE PROVIDER REPORTED THAT THERE IS NO INDURATION AND/OR SIGNS OF INFECTION AT THE SITE, AND THAT THE PATIENT HAD A SIGNIFICANT AMOUNT OF CELLULITE. THE PROVIDER REPORTED THAT THEY DRAINED OUT ANY POST PROCEDURE FLUID AFTER THE TREATMENT. PATIENT WAS STARTED ON BROMALINE AND ARNICA. THE PROVIDER WAS ADVISED TO DRAIN THE SEROMAS AND INSTRUCT THE PATIENT TO WEAR COMPRESSION GARMENTS.

  Patient problems: Seroma

  MAUDE report 22879920 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS TREATED WITH AVÉLI TWO MONTHS AGO AND THE PATIENT DEVELOPED A 5CM X 2CM SEROMA ON THE LEFT LATERAL THIGH APPROXIMATELY ONE WEEK AFTER TREATMENT. IT WAS REPORTED THAT THE PHYSICIAN DRAINED APPROXIMATELY 5CC OF FLUID, AND NO SIGNS OR SYMPTOMS OF INFECTION WERE OBSERVED. THE PROVIDER HAS CONTINUED TO DRAIN THE SEROMA BIWEEKLY FOR A TOTAL OF FIVE PROCEDURES, REMOVING NO MORE THAN 5CC OF SEROSANGUINEOUS FLUID EACH TIME. THROUGHOUT THIS PROCESS, THERE HAVE BEEN NO INDICATIONS OF INFECTION. ADDITIONALLY, THE PROVIDER ADMINISTERED A DOXYCYCLINE GAVAGE ONE WEEK AGO, BUT THERE HAS BEEN NO NOTICEABLE REDUCTION IN THE SIZE OF THE SEROMA AS OF YESTERDAY. DR. (B)(6) WOULD LIKE CLINICAL SUGGESTIONS ON HOW TO RESOLVE THE SEROMA. HE ADMITTED THAT HE NEVER HAD THE PATIENT USE ANY TYPE OF COMPRESSION GARMENT POST PROCEDURE. ON 05/01/25, THE PHYSICIAN REPORTED VIA EMAIL THAT THE SEROMA DID NOT RESOLVE WITH MULTIPLE MODALITIES AND NEEDS TO BE SURGICALLY CLOSED NOW.

  Patient problems: Seroma

  MAUDE report 22048752 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT 4 WEEKS AFTER BEING TREATED WITH AVELI FOR CELLULITE ON (B)(6) 2025 THAT INSTEAD OF A DIMPLE SHE HAS A "RIDGE" ON HER BUTTOCKS. ON (B)(6) 2025, THE PATIENT PROVIDED ADDITIONAL INFORMATION: "I WORE THE COMPRESSION GARMENT FOR 4 WEEKS . THE FIRST 3 WEEK ALL THE TIME. I COULD FEEL IT 1 WEEK LATER AND IT WAS VISIBLE 2 WEEKS LATER. THE "RIDGE/ SEROMA" WAS DRAINED 2 WEEKS LATER." THE PATIENT REPORTED THAT AFTER MASSAGING THE AREA THE RIDGE IS STILL THERE BUT MIGHT HAVE GOTTEN A BIT SMALLER AND IS STILL VISIBLE AND PALPABLE.

  Patient problems: Seroma

  MAUDE report 22048576 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AVELI CELLULITE RELEASE OF BILATERAL BUTTOCKS WITH A DENSE CLUSTER, ESSENTIALLY ON BOTH SIDES WITH SCATTERED SMALLER CLUSTERS LATERALLY AND INFERIORLY. IT WAS REPORTED THAT THE AVELI PATIENT RETURNED TO THE CLINIC AT 2 WEEKS POST PROCEDURE WITH FLUID FILLED SACS IN THE BILATERAL BUTTOCKS IN THE AREA OF CELLULITE SEPTA RELEASE. UNDER LOCAL INFILTRATION, THE PROVIDER REPORTED THAT THEY CREATED A TUNNEL UPWARDS TO THE INNER CONNECTING POCKETS OF SEROMA. THE TUNNEL WAS MADE LARGER AND A STERILE DRAIN WAS PLACED ALONG THE SUBCUTANEOUS TUNNEL AND SUTURED INTO PLACE TO ALLOW DRAINAGE. THE RIGHT DRAINAGE STAYED IN PLACE AND THAT SEROMA WAS COMPLETELY RESOLVED AT THE TIME OF DRAIN REMOVAL ON DAY 6. THE LEFT SIDE HAD FALLEN OUT AND HAD ONLY A SLIGHT FLUID COLLECTION. BY DAY 8, THE PATIENT COMPLAINED OF A COLLECTION OF FLUID ON THE LEFT SIDE AND SOME WARMTH. THE PATIENT RETURNED TO THE CLINIC AND THE PROVIDER CREATED A SEPARATE NEW TUNNEL FROM THE GLUTEAL CREASE UP TO THE POCKET AND PLACED ANOTHER PENROSE DRAIN. THE PROVIDER REMOVED ANOTHER 40 CC OF FLUID FROM THAT POCKET. THE PATIENT HAS NOT REPORTED ANY RECURRENCE.

  Patient problems: Seroma

  MAUDE report 21886973 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AVELI PATIENT REPORTED THAT APPROXIMATELY 5 WEEKS AFTER HER PROCEDURE SHE WAS EXPERIENCING "NERVE PAIN" AS WELL AS A "POCKET OF SKIN THAT FEELS SEPARATED FROM THE FAT." PATIENT REPORTED THAT HER PROVIDER REMOVED 40CC OF FLUID FROM THE RIGHT BUTTOCK. HER PROVIDER PRESCRIBED GABAPENTIN TO ADDRESS THE PAIN AND IT IMPROVED.

  Patient problems: Seroma; Unspecified Nervous System Problem

  MAUDE report 20741510 ↗
• MalfunctionOct 24, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A PROVIDER IS REUSING DEVICES ON MULTIPLE PATIENTS. IT WAS REPORTED THAT THE PROVIDER IS USING ALCOHOL TO CLEAN THE DEVICE AND THEN INSERTING THE ENTIRE DEVICE IN A CLEANING SOLUTION. THE REPORTER WISHES TO REMAIN ANONYMOUS.

  Patient problems: Unspecified Infection

  MAUDE report 20529215 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NEGATIVE REVIEW OF AVÉLI WAS WRITTEN ON THE REALSELF.COM ONLINE FORUM FOR PLASTIC SURGERY AND COSMETIC PROCEDURES. THE ALLEGED PATIENT REPORTED THAT THEY HAD THE AVÉLI PROCEDURE AND COMPLAINED OF DIMPLES, INDENTATIONS, AND HARD LUMPS ON THE BUTTOCKS. THE INDIVIDUAL REPORTED A "WEIRD SHAPE LIKE A BAD BBL" BUT THEY DID NOT HAVE A BBL. ANOTHER USER COMMENTED ON THE POST "HI, I WOULD DEFINETLY NOT WORRY. EASIER SAID THAN DONE BUT HONESTLY IT LOOKS LIKE YOU NEED TO HAVE YOUR DOCTOR DRAIN YOUR SEROMA. MY BUTT LOOKED SAGGY AND HEAVY LIKE THAT TOO WHEN I WASN'T WEARING MY COMPRESSION SHORTS. EVERYTHING IS MOSTLY HEALED AND SMOOTH NOW, MY BUTT IS STILL FIRM AND I'M MASSAGING OUT NODULES." THE ORIGINAL POSTER REPLIED "THANK YOU! YOU WERE RIGHT! HE DRAINED IT AND ALREADY LOOKS MUCH BETTER. I APPRECIATE YOU!" THE POST WAS REMOVED THE NEXT DAY FROM THE WEBSITE.

  Patient problems: Seroma; Subcutaneous Nodule

  MAUDE report 19155321 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 22 CELLULITE DEPRESSIONS WERE TREATED WITH AVELI, AND, APPROXIMATELY 4 WEEKS AFTER THE PROCEDURE, 30 CC'S OF FLUID WERE DRAINED FROM A SEROMA ON THE BUTTOCKS. IT WAS REPORTED THAT THREE DAYS LATER, 25 CC'S OF FLUID WERE DRAINED FROM A LARGER SEROMA ON THE BUTTOCKS, AND A FEW SMALL AREAS WERE DRAINED ON THE POSTERIOR SIDE. NODULES WERE ALSO REPORTED AND ARE DISSIPATING WITH MASSAGE AS OF ONE MONTH POST PROCEDURE. SIGNIFICANT BRUISING WAS REPORTED ON DAY 2 AFTER THE AVELI TREATMENT. COMPRESSION GARMENTS WERE WORN FOR TWO WEEKS AFTER THE PROCEDURE. THE BRUISING IS REPORTED TO BE ONGOING APPROXIMATELY ONE MONTH AFTER THE PROCEDURE.

  Patient problems: Ecchymosis; Seroma; Subcutaneous Nodule

  MAUDE report 19016503 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLETED THE AVELI PROCEDURE ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT PRESENTED WITH A SEROMA AND HAD APPROXIMATELY 35 CC OF CLEAR RED FLUID REMOVED. THE PHYSICIAN REPORTED THAT LIPOSUCTION WAS ALSO PERFORMED IN THE AREA AND THAT THE LIPOSUCTION COULD HAVE CONTRIBUTED TO THIS ADVERSE EVENT.

  Patient problems: Hematoma; Seroma

  MAUDE report 18522328 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD OVER 50 CELLULITE DIMPLES TREATED WITH AVELI. AT 6 WEEKS POST TREATMENT, IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SOME RESIDUAL SHADOWING (BRUISING) AND HAD A SEROMA WHERE 40CC'S HAD TO BE ASPIRATED. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING WHAT SHE DESCRIBES AS "MARBLES" UNDER THE SURFACE OF HER SKIN AND THAT SHE BEGAN MASSAGING HERSELF ~2 WEEKS PRIOR PER THE SURGEON'S RECOMMENDATION. PATIENT REPORTED INDURATIONS THE SIZE OF A GOLF BALL THAT CAN BE SEEN THROUGH HER CLOTHES.

  Patient problems: Local Reaction; Seroma; Skin Discoloration

  MAUDE report 18231984 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A BBL PERFORMED BY ANOTHER PROVIDER APPROXIMATELY 6 MONTHS BEFORE THE AVÉLI PROCEDURE FOR CELLULITE. DURING THE PRE-AVÉLI CONSULT THE PHYSICIAN PALPATED AND FELT MORE THAN A DOZEN FIRM AREAS THAT HE DESCRIBED AS "OIL CYSTS" OR "FAT NECROSIS" FROM THE PREVIOUS BBL PROCEDURE, PRIMARILY IN THE INFERIOR BUTTOCKS. THE AVÉLI PROCEDURE WAS PERFORMED AS NORMAL, BUT DURING THE EXPRESSION OF THE ANESTHESIA FLUID AT THE END OF THE CASE, THE PHYSICIAN OBSERVED OIL FROM THE ENTRY SITE CONSISTENT WITH DRAINING AN OIL CYST. THE ONE-WEEK POST-AVÉLI FOLLOW UP WAS NORMAL WITH NO SEROMA OBSERVED. AT APPROXIMATELY 5 WEEKS FOLLOW UP THE PHYSICIAN ASPIRATED APPROXIMATELY 140CC OF SEROUS FLUID FROM THE INFERIOR RIGHT BUTTOCKS.

  Patient problems: Seroma

  MAUDE report 17836854 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS PREVIOUSLY REPORTED THAT A PATIENT TREATED FOR CELLULITE WITH AVELI SUBSEQUENTLY DEVELOPED A SIGNIFICANT LUMP ON THE LEFT THIGH. REVELLE LEARNED ON 8/11/2023 THAT THE LUMP WAS DIAGNOSED AS A SEROMA AND AN UNKNOWN VOLUME OF FLUID WAS DRAINED. IT WAS REPORTED THAT THE AREA IS IMPROVING. ON 8/17/2023 REVELLE WAS PROVIDED ADDITIONAL INFORMATION. ON (B)(6) 2023 60 ML WAS DRAINED FROM THE SEROMA. ONE WEEK LATER, AN ADDITIONAL 30 ML WAS DRAINED.

  Patient problems: Seroma

  MAUDE report 17513315 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT TREATED WITH AVELI WAS VERY BRUISED IN THE RIGHT OUTER THIGH POST-OP. AT FOLLOW UP THE PATIENT PRESENTED WITH A SEROMA. THE PHYSICIAN DRAINED 80CC OF OLD BLOOD FROM THE BRUISED AREA AT 1-WEEK POST-OP, AND PERFORMED SERIAL DRAINAGES SEVERAL TIMES.

  Patient problems: Seroma

  MAUDE report 17302337 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT TREATED WITH AVELI PRESENTED WITH A SEROMA APPROXIMATELY ONE MONTH POST-PROCEDURE. AN ESTIMATED VOLUME OF 20CC MAX IN THE LEFT BUTTOCK WAS DRAINED OVER SEVERAL FOLLOW UP VISITS. THE AREA WHERE THE SEROMA WAS OBSERVED WAS REPORTED TO CORRELATE WITH AN AREA TREATED AGGRESSIVELY AS THE PATIENT HAD SEVERAL LARGE DIMPLES IN ONE LOCATION.

  Patient problems: Seroma

  MAUDE report 17302252 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH NUMEROUS CELLULITE DEPRESSIONS, SOME IN CLOSE PROXIMITY TO ONE ANOTHER. THE CELLULITE DEPRESSIONS WERE TREATED WITH AVELI. LIPO 360 AND FAT GRAFTING WERE ALSO PERFORMED IN OTHER AREAS. THE PATIENT PRESENTED WITH SEROMAS ON BOTH BUTTOCKS AND AN AREA IN THE BUTTOCKS DESCRIBED AS "SEPARATION OR DETACHED FEELING" APPROXIMATELY 2 WEEKS POST PROCEDURE. THE PATIENT HAS BEEN USING COMPRESSION AS DIRECTED. ON BOTH BUTTOCKS HUNDREDS OF CC'S OF FLUID WERE DRAINED (TOTAL) OVER 3-4 FOLLOW-UP VISITS. THE LAST VISIT WAS ABOUT 80 CC'S TOTAL FROM BOTH BUTTOCKS. ULTRASOUND AT THE LAST VISIT CONFIRMED THE FLUID WAS GONE AFTER THE LAST DRAINING.

  Patient problems: Seroma

  MAUDE report 17301983 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON MAY 22, 2023 THAT A PATIENT TREATED WITH AVÉLI ON (B)(6) 2023 DEVELOPED A SEROMA ON THE BUTTOCK AND A SEROMA ON THE THIGH. THE SEROMAS WERE DRAINED BY A HEALTHCARE PROVIDER SUCCESSFULLY. ULTRASOUND CONFIRMED THERE IS NO RESIDUAL FLUID. IT WAS ALSO REPORTED THAT THERE IS A FIRM LUMP ON THE BUTTOCK THAT THE PATIENT AND PHYSICIAN CAN PALPATE BUT IS NOT VISIBLE ON THE SKIN SURFACE. THE COURSE OF ACTION IS TO HAVE THE PATIENT CONTINUE TO MASSAGE THE LUMP AND OBSERVE WHETHER IT GETS SMALLER BEFORE CONSIDERING AN INJECTION OR OTHER COURSE OF ACTION TO REDUCE IT. ON 9/22/2023 IT WAS REPORTED THAT THE PATIENT PRESENTED WITH FIBROSIS IN THE AREA OF THE RECURRENT SEROMA. THE PHYSICIAN IS CONSIDERING THE USE OF A TOPICAL TRIPEPTIDE/HEXAPEPTIDE PRODUCT IN COMBINATION WITH CROSS OR TRANSVERSE FRICTION MASSAGE TO ADDRESS THE FIBROSIS.

  Patient problems: Fibrosis; Local Reaction; Seroma

  MAUDE report 17135967 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AVELI ON (B)(6) 2023. THE PATIENT WAS SEEN ONE MONTH LATER FOR FOLLOW UP. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN AREA THAT WAS WARM TO THE TOUCH AND A SEROMA/HEMATOMA WAS SUSPECTED. THE HCP ASPIRATED THE AREA AND REMOVED 54 CC'S OF BLOOD. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. IT WAS REPORTED THAT THE AREA HAD IMPROVED.

  Patient problems: Seroma

  MAUDE report 16694521 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NEGATIVE REVIEW OF AVÉLI WAS REPORTED ON THE REALSELF.COM ONLINE FORUM FOR PLASTIC SURGERY. THE ALLEGED PATIENT REPORTED THAT THEY HAD THE AVÉLI PROCEDURE COMBINED WITH BRAZILIAN BUTT LIFT (BBL). THE PATIENT WROTE "AVOID COMBINED PROCEDURE THEY MAKE IT LIKE IT'S THE BEST IT'S TERRIBLE WITH A BBL , I GOT 3-DEGREE BURNS, BLOW OUTS AROUND THE BURNS LUMPS I MAY HAVE TO DEAL WITH THIS FOR THE REST OF MY LIFE, DISCOLORED SKIN. I'M MORTIFIED PLEASE DON'T DO IT ANYONE THINKING ABOUT IT GET THE BBL FIRST THEN MAYBE IF U WANT TO TRY, NOT TOGETHER NO ONE TELL YOU THE RISKS ONLY THE REWARDS. I CAN'T EVEN BE NAKED IN FRONT OF MY HUSBAND WITHOUT FEELING ASHAMED. THIS IS A NIGHTMARE PROCEDURE COMBINED." REVELLE WAS ABLE TO CONTACT THE PATIENT. THE PATIENT RESPONDED: "YEA SO, I HAD A BBL W AVELI AND THE SPOTS THAT AVELI WAS USED FOR DENTS CELLULITE DEVELOPED BLISTERS, WHICH TURNED INTO BURNS SO THAT'S WHY I THOUGHT IT HAD SOMETHING TO DO WITH THE AND I DID GO TO A DOUBLE BOARD-CERTIFIED PLASTIC SURGEON AND SPENT A LOT OF MONEY. TRAVELED TO HUSTON LUX RECOVERY HOUSE I SPENT OVER 30K THE DOC SAID IT WAS A COMBINATION ON BOTH. I HAVE PICTURES." THE PATIENT PROVIDED PHOTOS AND ADDED: "SO ALL THE DO

  Patient problems: Cellulitis; Hematoma; Hyperemia; Local Reaction; Necrosis; Seroma

  MAUDE report 16588182 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS PREVIOUSLY REPORTED THAT A FEMALE PATIENT DEVELOPED A WOUND REQUIRING DEBRIDEMENT FOLLOWING A TUMMY TUCK, LIPO 360, AND AVÉLI PROCEDURES. FAT NECROSIS WAS FOUND IN THE AREA UNDERNEATH THE WOUND, AND THE PATIENT WOULD LIKELY NEED A SURGERY TO ADDRESS THE VOLUME LOSS. THE TREATING PHYSICIAN REPORTED THAT THE WOUND WAS NEAR THE BONEY PROMINENCE OF THE ISCHIUM AND IS CONSISTENT WITH A PRESSURE WOUND. THE PATIENT RETURNED FOR FOLLOW UP TWO MONTHS AFTER THE WOUND DEBRIDEMENT AND IT WAS REPORTED THAT THE WOUND BED IS HEALING WELL. ON (B)(6) 2023, THE TREATING PHYSICIAN PROVIDED AN UPDATE REGARDING THE PATIENT. IT WAS REPORTED THAT THE PATIENT'S FAT NECROSIS ON THE LEFT BUTTOCK IS HEALING WELL. THE OPENING IN THE SKIN IS SMALLER AND IS NOW SEVERAL MILLIMETERS WIDE. IT WAS REPORTED THAT THE PATIENT STILL HAS SOME AREAS OF FIRMNESS ON THE RIGHT BUTTOCKS AND IS RETURNING TO THE OFFICE TWICE PER WEEK FOR MASSAGE TO BREAK UP THE AREAS OF FIRMNESS. FOR FUTURE COSMETIC IMPROVEMENT, THE PHYSICIAN IS PLANNING 2-3 TREATMENTS WITH SCULPTRA® OVER SEVERAL MONTHS ON BOTH THE LEFT AND RIGHT BUTTOCKS TO FILL THE VOLUME DEFICIENCY AFTER THE FAT NECROSIS ON THE LEFT SIDE AND TO SOFTEN THE RIGHT SIDE.

  Patient problems: Abscess; Local Reaction; Localized Skin Lesion; Necrosis; Pressure Sore/Ulcer

  MAUDE report 16236456 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH DEPRESSIONS OF MEDIUM AVERAGE DEPTH AND MILD LAXITY. TEN DEPRESSIONS WERE TREATED: 6 ON THE LEFT BUTTOCK AND 4 ON THE RIGHT BUTTOCK. IT WAS REPORTED THAT AT TWO WEEKS POST PROCEDURE SMALL POCKETS OF SWELLING WERE OBSERVED IN THE TREATMENT AREA. PATIENT WAS WEARING COMPRESSION GARMENTS AND WAS ADVISED TO MASSAGE 3 TIMES DAILY. THE PHYSICIAN REPORTED THAT THEY EXAMINED THE PATIENT AND DIAGNOSED SEROMAS ON THE LEFT AND RIGHT BUTTOCKS. THE PHYSICIAN DRAINED 15-20 CC FROM EACH OF THE TWO SEROMAS.

  Patient problems: Seroma

  MAUDE report 16160032 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AVÉLI PATIENT IS HEALING WELL BUT DEVELOPED 5 SPOTS OF CELLULITIS ABOUT 5 DAYS AFTER TREATMENT. THE PATIENT WAS TREATED FOR 12 CELLULITE DEPRESSIONS: 2 ON LEFT BUTTOCK, 1 ON LEFT LATERAL THIGH, 3 ON RIGHT BUTTOCK, 1 ON RIGHT POSTERIOR THIGH, AND 5 ON RIGHT LATERAL THIGH. THE PATIENT STARTED AUGMENTIN AND WAS DOING WELL BUT THE SPOTS CAME BACK. THE PATIENT THEN STARTED BACTRIM AND ALL SPOTS APPEARED TO BE DOING WELL WITH ONE DAY LEFT FOR THE BACTRIM. THE PATIENT WAS REPORTED TO HAVE SENSITIVE SKIN AND SHAVED THE MORNING OF TREATMENT.

  Patient problems: Cellulitis

  MAUDE report 15934706 ↗
• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INSTAGRAM USER REPORTED: "I HAD AVELI DONE IN MIAMI ALMOST 3 WEEKS AGO, THE AMOUNT OF SWELLING AND BRUISING IS BEYOND ANY SURGERY, BUT THAT IS NOT EVEN THE WORSE, THE SEROMAS, OMG, WHEN WILL IT ALL GO AWAY? ANY SUGGESTIONS." INSTAGRAM USER STATED IN THE POSTING THAT SHE HAD REACHED OUT TO HER PROVIDER AND HE INDICATED THAT HER SYMPTOMS ARE NORMAL. REVELLE ATTEMPTED TO CONTACT PATIENT BY EMAIL ON 10/7/22 FOR MORE INFORMATION, AND AGAIN BY TEXT MESSAGE ON 10/11/22 AND AGAIN BY PHONE ON 10/13/22 AND SHE COULD NOT BE REACHED. VOICEMAIL WAS NOT AVAILABLE. THE PATIENT'S NAME AND TREATMENT PROVIDER'S NAME IS UNKNOWN.

  Patient problems: Seroma

  MAUDE report 15660236 ↗
• InjuryOct 18, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT PRESENTED WITH DEPRESSIONS OF MEDIUM AVERAGE DEPTH AND MODERATE LAXITY. PATIENT HAD PRIOR ABDOMINOPLASTY. 57 DEPRESSIONS WERE TREATED: 9 LEFT BUTTOCKS; 5 LEFT POSTERIOR THIGH; 12 LEFT LATERAL THIGH; 15 RIGHT BUTTOCK; 5 RIGHT POSTERIOR THIGH; 11 RIGHT LATERAL THIGH. IT WAS REPORTED THAT THE PATIENT DEVELOPED TWO MINOR SEROMAS ON THE LEFT AND RIGHT LATERAL THIGHS 2 DAYS AFTER HER PROCEDURE. THE PHYSICIAN DRAINED 2-3 CCS OF FLUID FROM EACH SITE ON THE LATERAL THIGH AND APPLIED ADDITIONAL COMPRESSION. IT WAS REPORTED THAT THE PATIENT IS DOING GREAT.

  Patient problems: Seroma

  MAUDE report 15621021 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH DEEP AVERAGE DEPRESSION DEPTH, MODERATE LAXITY, AND VOLUME DEFICIENCY/SCARRING IN THE LEFT BUTTOCKS. PATIENT HAD PRIOR ABDOMINOPLASTY. 40 DEPRESSIONS WERE TREATED: 9 LEFT BUTTOCK; 7 LEFT POSTERIOR THIGH; 1 LEFT LATERAL THIGH; 18 RIGHT BUTTOCK; 4 RIGHT POSTERIOR THIGH; 1 RIGHT LATERAL THIGH. IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEROMA ON THE LEFT BUTTOCKS WHERE THERE IS A DEEP DEPRESSION/SCAR APPROXIMATELY 2 WEEKS AFTER HER PROCEDURE. THE PHYSICIAN DRAINED THE SEROMA 2 TIMES. THE TOTAL VOLUME DRAINED WAS 90 CC EACH TIME.

  Patient problems: Seroma

  MAUDE report 15620817 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH DEPRESSIONS OF MEDIUM AVERAGE DEPTH AND MODERATE LAXITY. PATIENT HAD FLANK AND LATERAL THIGH LIPOSUCTION ONE YEAR PRIOR. SEVEN DEPRESSIONS WERE TREATED: ONE LEFT POSTERIOR THIGH; ONE LEFT LATERAL THIGH; ONE RIGHT BUTTOCK; FOUR RIGHT LATERAL THIGH. IT WAS REPORTED THAT THE PATIENT DEVELOPED A SEROMA ON THE RIGHT LATERAL THIGH AFTER HER PROCEDURE. THE PHYSICIAN DRAINED THE SEROMA 4 TIMES. THE TOTAL VOLUME DRAINED WAS 25CC 1ST TIME, 10CC 2ND TIME, 10CC 3RD TIME, 5CC FINAL TIME. AT APPROXIMATELY ONE MONTH POST PROCEDURE, THE PATIENT REPORTED SHE'S PLEASED WITH HER OUTCOME AND THE SEROMA WASN'T A BOTHER AT ALL. SHE DID FOLLOW POST OP PROTOCOL AND WORE COMPRESSION PANTS 1 WEEK POST OP. AT TWO MONTHS POST PROCEDURE THE PATIENT IS DOING WELL. THERE IS NO PAIN OR DISCOMFORT BUT THERE IS STILL SOME DISCOLORATION/BRUISING AND HARDNESS IN THE AREA. THE PATIENT INDICATED THAT THE AREA LOOKS AND FEELS GOOD BUT SOME DIMPLES REMAIN VISUALLY IN PHOTOS.

  Patient problems: Seroma

  MAUDE report 15395211 ↗