Carriere® SLX 3D™ 776-LR4-HK-RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190707057756), received between Sep 29, 2023 and Sep 29, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Sharp Edges” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED IN THE CUSTOMER COMPLAINT FORM THAT BRACKET LR4 IN THE PROVIDED KIT HAD SHARP EDGES CAUSING CHEEK IRRITATION, CUTTING THE CHEEK ON THE LOWER RIGHT OF THE PATIENT AND CAUSING LARGE SORES THAT DID NOT HEAL. THE SYMPTOMS BEGAN THE DAY AFTER THE BRACKET WAS PLACED. THE BRACKET NEEDED TO BE REMOVED AND REPLACED WITH A DIFFERENT BRAND. THE 34-YEAR OLD FEMALE PATIENT WAS PRESCRIBED KENALOG IN ORABASE, A TOPICAL STEROID. SHE WAS ALSO ADVISED TO TAKE OTC PAIN MEDICATION SUCH AS IBUPROFEN AND TYLENOL.

  Patient problems: Abrasion

  MAUDE report 17847181 ↗