Men's Liberty Acute BIO2102610Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00653599000847), received between May 31, 2022 and Oct 7, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS CONTACTED ON (B)(6) 2022 FOR FOLLOW-UP TO FIRST-TIME PRODUCT USE. PATIENT'S WIFE STATED THAT THE PATIENT WAS HOSPITALIZED DUE TO UTI AFTER STARTING USE OF MEN'S LIBERTY. PATIENT'S WIFE STATED THAT HE WORE ONE ML FOR 3 DAYS, DEVELOPED AN INFECTION, WAS IN THE HOSPITAL, AND TO CALL HER BACK LATER. PRODUCT SPECIALIST CALLED BACK. PATIENT'S WIFE STATED HE WOULD START USING ML AGAIN NOW THAT HE IS CLEARED OF INFECTION. PRODUCT SPECIALIST GAVE HER SUGGESTION FOR RECOMMENDED WEAR TIME (24 HOURS), PROPER POSITIONING TO HELP PREVENT BACKFLOW, AND WHAT TO WATCH FOR. PATIENT'S WIFE WAS UNABLE TO PROVIDE THE MEN'S LIBERTY LOT NUMBER.

  Patient problems: Urinary Tract Infection

  MAUDE report 15564321 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISTRIBUTOR INFORMED BIODERM OF A COMPLAINT THEY RECEIVED BY ONE OF THEIR CUSTOMERS (HOSPITAL). THE HOSPITAL REPORTED AN UNCIRCUMCISED MALE PATIENT DEVELOPED SIGNIFICANT EDEMA, FLUID OVERLOAD, AND PURPLE BLISTER AREAS ON HIS PENIS WHILE USING MEN'S LIBERTY ACUTE. THEY REPORTED THE PATIENT WAS EVALUATED BY THE UROLOGIST, WHO REMOVED THE MLA AND INSERTED A FOLEY CATHETER.

  Patient problems: Swelling/ Edema

  MAUDE report 14859975 ↗
• InjuryMay 31, 2022Unexpected Therapeutic Results

  IT WAS REPORTED THAT AN UNCIRCUMCISED MALE PATIENT HAD AN EXTERNAL URINARY DRAINAGE SYSTEM APPLIED TO HIS PENIS WHEN HE EXPERIENCED AN ADVERSE EVENT AND REQUIRED A FOLEY CATHETER.

  Patient problems: Swelling/ Edema

  MAUDE report 14550613 ↗