Belotero Balance 8700M0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M2138700M05), received between May 23, 2016 and Aug 16, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A (B)(6) YEAR OLD FEMALE PATIENT WAS INJECTED WITH 0.3CC OF BELOTERO TO UNDER THE EYES. LOT 321330 (EXPIRY 11/30/2019). MEDICAL HISTORY POSITIVE FOR INJECTIONS OF RADIESSE, BELOTERO, VOLBELLA, VOLUMA, AND JUVEDERM SINCE 2013. CONCOMITANT MEDICATIONS REPORTED AS NONE. IMMEDIATELY AFTER INJECTION WITH BELOTERO, THE PATIENT EXPERIENCED BLANCHING DOWN THE CHEEKS TO THE LIP AND ONTO SIDE OF NOSE. HER LIP WAS PURPLE. CORRECTIVE TREATMENT REPORTED AS HYALURONIDASE 2CC, NITROPASTE, AND HOT COMPRESSES. WITHIN ONE HOUR, THE BLANCHING RESOLVED AND THE LIP COLOR AND PERFUSION WERE BACK TO NORMAL. IN THE OPINION OF THE REPORTER, THE EVENTS WERE RELATED TO BELOTERO. FOLLOW UP INFORMATION WAS RECEIVED FROM THE REPORTER ON (B)(6) 2019: THE CASE WAS UPGRADED TO SERIOUS. IN THE OPINION OF THE REPORTER, TREATMENT WAS MEDICALLY NECESSARY TO PREVENT DAMAGE AND TISSUE NECROSIS TO THE PATIENT'S FACE. THE PATIENT EXPERIENCED SIGNIFICANT DARKENING AND BLANCHING, MOVING ACROSS THE AREA. TREATMENT WAS PERFORMED FOR AN HOUR OR SO, UNTIL THE TISSUE PERFUSION RETURNED TO NORMAL.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 8902277 ↗
• InjuryMar 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO 2135225-2018-00007. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN AND CONCERNS A FEMALE PATIENT (AGE NOT REPORTED) WHO WAS INJECTED WITH AN UNSPECIFIED MERZ PRODUCT ON AN UNSPECIFIED DATE FOR UNSPECIFIED INDICATION. (THE PHYSICIAN'S ORDER HISTORY NOTES ORDERS FOR BOTH RADIESSE+ AND BELOTERO). MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT REPORTED. AN UNSPECIFIED TIME POST INJECTION, THE PATIENT DEVELOPED NECROSIS OF THE TISSUE IN HER CHEEK AND NOSE. HER FACE WAS "SEVERELY DAMAGED AND PERMANENTLY SCARRED." CAUSALITY REPORTED AS RELATED. RADIESSE+ LOT NUMBER UNKNOWN AS PHYSICIAN HAS MORE THAN ONE LOT NUMBER IN HIS ORDER HISTORY. BELOTERO LOT NUMBER IS 321189. TREATMENT AND OUTCOME NOT REPORTED.

  Patient problems: Scarring

  MAUDE report 7320383 ↗
• InjuryJul 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A (B)(6) FEMALE PATIENT WAS INJECTED WITH BELOTERO. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT REPORTED. ON (B)(6) 2017, THE PATIENT WAS INJECTED WITH ONE SYRINGE OF BELOTERO TO THE CHEEKS. ON (B)(6) 2017, THE PATIENT DEVELOPED AN INFECTION IN THE LEFT CHEEK. TREATMENT REPORTED AS UNSPECIFIED ANTIBIOTICS AND HYALURONIDASE INJECTION. THE INFECTION IS RESOLVING. CAUSALITY NOT REPORTED. LOT NUMBER REPORTED AS 32185. ON 19-JUL-2017, FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN. MEDICAL HISTORY REPORTED AS NEGATIVE. CONCOMITANT MEDICATIONS REPORTED AS UNSPECIFIED VITAMINS. ON (B)(6) 2017, THE PATIENT WAS INJECTED WITH VOLUMA "DEEP" IN THE CHEEKS AND BELOTERO "ON THE SURFACE." ON (B)(6) 2017, THE PATIENT PRESENTED WITH REDNESS, SWELLING AND TENDERNESS TO THE LEFT CHEEK AND WAS DIAGNOSED WITH CELLULITIS. A MRI "THE NEXT DAY" WAS CONSISTENT WITH CELLULITIS, WITHOUT ABSCESS. TREATMENT REPORTED AS INTRAVENOUS CEFTRIAXONE, ADMINISTERED IN THE PHYSICIAN'S OFFICE, AND ORAL CEPHALEXIN. THE PHYSICIAN BELIEVES SKIN BACTERIA ENTERED THE SITE DURING ONE OF THE "PUNCTURES." ON 24-JUL-2017, THE LOT NUMBER WAS CLARIFIED TO BE 321285.

  Patient problems: Cellulitis

  MAUDE report 6740795 ↗
• InjuryMay 23, 2016Insufficient Device Problem Information

  ON 27-MAY-2015, A (B)(6) MALE PATIENT REPORTED HE WAS INJECTED WITH 1/2 TO 1/3 SYRINGE OF BELOTERO TO UNDER THE EYES "A COUPLE OF WEEKS AGO". FOUR DAYS POST INJECTION, THE AREA UNDER HIS LEFT LOWER EYELID BECAME IRRITATED, INFLAMED, AND PUFFY. HE WENT BACK TO INJECTOR, WHO THOUGHT HE HAD AN INFECTION OR ALLERGIC REACTION AND PUT HIM ON ALLEGRA AND DOXYCYCLINE 150MG DAILY. AFTER 4-5 DAYS ON THE MEDICATIONS, THE LEFT LOWER EYELID "CALMED DOWN SOME". HE FOLLOWED UP WITH THE INJECTOR, WHO SAID THE EYE LOOKED MUCH BETTER. ON (B)(6) 2015, PATIENT WENT TO AN OPHTHALMOLOGIST AND WAS TOLD HE HAD A STY UNDER THE LEFT EYELID. HE WAS PRESCRIBED TOBRAMYCIN/DEXAMETHASONE DROPS. HIS VISION WAS FINE. THE OPHTHALMOLOGIST FELT IT LOOKED LIKE "SOMETHING WAS UNDER THERE" IN THE LEFT LOWER EYELID AREA AND TOLD PATIENT HE MAY TRY TO INCISE THE AREA ON FOLLOW-UP. WHEN PATIENT WOKE UP THIS MORNING, THE RIGHT EYELID WAS PUFFY, RED AND SENSITIVE TO THE TOUCH. ON 27-MAY-2015, FOLLOW UP INFORMATION WAS RECEIVED FROM THE INJECTOR, WHO REPORTED PATIENT WAS INJECTED WITH 0.2CC (0.1CC TO EACH TEAR TROUGH AREA) OF BELOTERO ON (B)(6) 2015. PATIENT WAS FINE WHEN HE LEFT THE OFFICE POST TREATMENT. ON (B)(6) 2015, PAT

  Patient problems: Discharge; Inflammation; Irritation; Swelling

  MAUDE report 5673095 ↗