SKYN 7412Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00070907274125), received between Nov 15, 2022 and Nov 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionNov 15, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  REFERRED BY THE CONSUMER PRODUCT SAFETY COMMISSION OF THE UNITED STATES OF AMERICA. ON (B)(6) 2022, ME, (B)(6) AND MY WIFE WERE HAVING INTERCOURSE, WHEN THE CONDOM BROKE. THE CONDOM BROKE, AT THE TIP, WHILE EJACULATING, INSIDE OF MY WIFE. BECAUSE THE CONDOM BROKE, WHILE EJACULATING, INSIDE OF MY WIFE, THERE IS A GOOD CHANCE THAT MY WIFE WILL HAVE AN UNPLANNED PREGNANCY. I CONSIDER A PRODUCT THAT BREAKS, SUCH AS CONDOM, TO BE A DEFECTIVE PRODUCT, NO MATTER WHETHER THE DEFECT WAS INTENTIONAL OR NOT. THIS DEFECTIVE CONDOM WAS A LIFESTYLES SKYN, SYNTHETIC POLYISOPRENE CONDOM. THE CONDOM'S PACKAGE STATES DESCRIPTIVE DETAILS SUCH AS ELITE LARGE, ELITE GRAND FORMAT, LOT: 2107733116, EXP: 2026-06-30, NOM: 56MM, MFG/FAB: THAILAND. I WOULD LIKE THIS ORGANIZATION TO SEEK ANY AND ALL REMEDIES POSSIBLE FOR THIS DAMAGED PRODUCT, THAT I RELIED ON, TO PREVENT AN UNPLANNED PREGNANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797217 ↗