Men's Liberty 23046Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00653599000168), received between Jun 15, 2022 and Jun 20, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED IN TO REPORT DRAINING ISSUES WITH ML AND A UTI IN THE LAST MONTH OR TWO. PATIENT DID NOT REMEMBER WHEN, BUT MENTIONED HE WAS HOSPITALIZED AT (B)(6) HOSPITAL. PATIENT MENTIONED BLOCKING THE URINE BAG TUBE/ML BAG SOMETIMES WHILE SLEEPING. PRODUCT SPECIALIST WENT OVER PROPER POSITIONING TO ALLOW URINE TO FLOW AWAY FROM THE ANATOMY WITH GRAVITY. PATIENT SUPPLIED ML LOT # K35206. PRODUCT SPECIALIST LEFT MULTIPLE VOICEMAILS WITH THE PATIENT FOR FOLLOW-UP BUT COULD NOT BE REACHED. PRODUCT SPECIALIST ALSO LEFT A VOICEMAIL WITH THE HOSPITAL TO ACQUIRE DOCTOR'S NOTES CONFIRMING THE INFECTION, BUT NONE HAVE BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 22301760 ↗
• InjuryJun 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  FDA CONTACTED US THAT A PATIENT HAD SUBMITTED AN ADVERSE EVENT REPORT THROUGH THEIR MEDWATCH PROGRAM (FORM MW5170048). PATIENT DID NOT SUPPLY ANY PERSONAL INFORMATION TO CONTACT THEM. PATIENT STATED HE STARTED TO EXPERIENCE SORES AND BLISTERS ON THE TIP OF HIS ANATOMY WHERE MEN'S LIBERTY IS APPLIED. HE STATED HE DID NOT HAVE ANY ISSUES FOR 3 YEARS OF PRODUCT USE UNTIL HE STARTED TAKING THE MEDICATION SPIRONOLACTONE. PATIENT STATED HE TRIED A SKIN TEST OF MEN'S LIBERTY AT THE ADVICE OF HIS DERMATOLOGIST, AND THAT HE DID NOT HAVE ANY REACTION TO MEN'S LIBERTY DURING HIS SKIN TEST.

  Patient problems: Local Reaction

  MAUDE report 22301746 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS CONTACTED FOR FOLLOW UP. PATIENT'S WIFE STATED HE GOT A UTI FROM STICKING THE TOP OF HIS PENIS INTO THE ML TUBE IN ORDER FOR IT TO STAY ON LONGER. PATIENT'S WIFE STATED HE WAS IN REHAB FOLLOWING THE HOSPITAL STAY FOR THE UTI. PRODUCT SPECIALIST ADVISED STOPPING USE OF ML UNTIL COMPLETELY HEALED AND NOT TO STICK HIS ANATOMY INTO THE ML TUBE. PATIENT'S WIFE PROVIDED ML LOT # K32613. PRODUCT SPECIALIST LATER REACHED OUT TO THE PATIENT TO GET THE NAME OF THE HOSPITAL TO REQUEST DOCTOR'S NOTES ON PATIENT MEDICAL HISTORY AND CONFIRMATION OF INFECTION BUT WAS UNSUCCESSFUL. PATIENT IS A LONG-TIME USER, AND THE PATIENT'S WIFE STATED SHE WILL HELP HIM APPLY FROM NOW ON TO MAKE SURE IT IS DONE CORRECTLY.

  Patient problems: Urinary Tract Infection

  MAUDE report 21721500 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS CONTACTED FOR 30-DAY FOLLOW UP. PATIENT STATED HE IS NOT USING ML ANYMORE AS HE EXPERIENCED A UTI THAT WAS TREATED IN THE HOSPITAL. HE STATED HE WAS NOT SURE WHAT CAUSED IT BUT HAS SEVERAL HEALTH AILMENTS AND TAKES MEDICATION THAT CAN CAUSE UTIS. PATIENT STATED HE IS NOT USING ML AGAIN UNTIL HE CONSULTS WITH HIS UROLOGIST. PATIENT PROVIDED ML LOT # K29507. PRODUCT SPECIALIST LATER REACHED OUT TO THE PATIENT TO GET THE NAME OF THE HOSPITAL TO REQUEST DOCTOR'S NOTES ON PATIENT MEDICAL HISTORY AND CONFIRMATION OF INFECTION BUT WAS UNSUCCESSFUL. PATIENT WAS A FIRST-TIME USER AND HAD PREVIOUS CALLS WITH A PRODUCT SPECIALIST ABOUT LEAKING POSSIBLY DUE TO BACKFLOW, AND THE PRODUCT SPECIALIST ADVISED HIM TO BE MINDFUL OF POSITIONING TO PREVENT BACKFLOW.

  Patient problems: Urinary Tract Infection

  MAUDE report 21721142 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED IN REPORTING HE DOESN'T LIKE ML AND WANTED TO RETURN THE REMAINING SUPPLIES. PATIENT WAS A FIRST-TIME USER AND DID NOT HAVE A DOCUMENTED PRODUCT WALKTHROUGH WITH A PRODUCT SPECIALIST, AS THE PRODUCT SPECIALIST NOTED HE DECLINED A WALKTHROUGH AND SAID HE WOULD CALL BACK IF HE WANTED THE WALKTHROUGH ((B)(6) 2025). HE STATED THE SECOND TIME HE TRIED ML, HE HAD A TREMENDOUS LEAK IN THE MIDDLE OF THE NIGHT. HE STATED THE CONNECTION BETWEEN ML AND THE BED BAG FAILED WHICH CAUSED THE LEAK. HE STATED HE GOT A UTI LATER THAT DAY WITH BLOOD IN HIS URINE. PATIENT STATED HE WAS ADMITTED TO THE HOSPITAL WITH A UTI. PRODUCT SPECIALIST TRIED TO ASK ABOUT APPLICATION, BUT HE WAS FIRM ON STOPPING USE OF ML AND DECLINED ANY TYPE OF TROUBLESHOOTING OR FURTHER QUESTIONS. PATIENT STATED HE COULD NOT LOCATE THE LOT #. PER HIS ONLY SALES ORDER ON RECORD, IT CONSISTED OF ML LOT # 2025-0131. PRODUCT SPECIALIST REACHED OUT TO THE PATIENT TO GET THE NAME OF THE HOSPITAL TO REQUEST DOCTOR'S NOTES ON PATIENT MEDICAL HISTORY AND CONFIRMATION OF INFECTION BUT WAS UNSUCCESSFUL.

  Patient problems: Urinary Tract Infection

  MAUDE report 21619526 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S WIFE CALLED IN REPORTING THE PATIENT WAS IN THE HOSPITAL WITH A UTI AFTER USING MEN'S LIBERTY. SHE STATED HE WAS PUT ON 5 DAYS OF ANTIBIOTICS. SHE MENTIONED THAT A SMALL PORTION OF URINE IN THE ML TUBE DOESN'T DRAIN DOWN INTO THE COLLECTION POUCH. PRODUCT SPECIALIST WENT OVER APPLICATION AND TROUBLESHOOTED WAYS TO ENSURE PROPER DRAINIAGE OF URINE. PATIENT'S WIFE STATED THAT SHE APPLIES THE FACEPLATE SEAL TIGHTLY, AND THE PRODUCT SPECIALIST INFORMED HER TO APPLY CORRECTLY WITHOUT IT BEING TOO TIGHT TO PREVENT INJURY. PATIENT'S WIFE STATED THEY WOULD REFRAIN FROM USING ML FOR ANOTHER WEEK UNTIL HE IS CLEARED OF THE UTI. SHE ALSO MENTIONED HE HAS HAD UTIS IN THE PAST BUT NOTHING CHRONIC. PATIENT'S WIFE PROVIDED ML LOT # K17601. PRODUCT SPECIALIST REACHED OUT TO THE DOCTOR ON FILE TO REQUEST DOCTOR'S NOTES ON PATIENT MEDICAL HISTORY AND CONFIRMATION OF INFECTION BUT WAS UNSUCCESSFUL.

  Patient problems: Urinary Tract Infection

  MAUDE report 20745360 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT SPECIALIST REACHED OUT TO THE PATIENT REGARDING REORDERING AND WAS INFORMED THAT THE PATIENT IS NOT CURRENTLY USING ML. PATIENT STATED HE FELL IN THE BATHROOM WEARING ML AND WAS UNABLE TO GET OFF THE GROUND FOR 14 HOURS BEFORE GETTING HELP TO THE HOSPITAL. PATIENT STATED HE WASN'T AWARE HE HAD A UTI UNTIL BEING DIAGNOSED AT HOSPITAL. PATIENT STATED AT THE HOSPITAL SENT HIM HOME WITHOUT ANY ANTIBIOTICS, LEADING TO A RELAPSE. PATIENT STATED HE PREFERS TO WEAR ML OVER DEPENDS/ABSORBENT PADS BUT IS AFRAID TO WEAR ML AFTER SUFFERING FROM UTI. PRODUCT SPECIALIST REACHED OUT TO THE DOCTOR ON TO REQUEST DOCTOR'S NOTES ON PATIENT MEDICAL HISTORY AND CONFIRMATION OF INFECTION BUT WAS UNSUCCESSFUL.

  Patient problems: Urinary Tract Infection

  MAUDE report 20745049 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED IN TO REPORT THAT HE WAS IN THE HOSPITAL FOR 5 DAYS WITH A UTI. PATIENT STATED HE HAS HAD THEM BEFORE, AND NOT QUITE SURE WHAT CAUSED IT. PATIENT STATED HE IS CURRENTLY USING A FOLEY CATHETER AND IS NOT SURE FOR HOW LONG. PATIENT WAS UNABLE TO PROVIDE A MEN'S LIBERTY LOT NUMBER. PER SAP NOTES, THE PATIENT WAS SHIPPED MEN'S LIBERTY LOT # J19107.

  Patient problems: Urinary Tract Infection

  MAUDE report 18273681 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS CONTACTED ON (B)(6) 2023 FOR FOLLOW-UP TO FIRST-TIME PRODUCT USE. PATIENT STATED HE LOVES THE PRODUCT, AND IT WORKED FINE, BUT AFTER 3 DAYS OF USE HE STARTED TO EXPERIENCE BURNING WHILE URINATING. PATIENT STATED HE PROBABLY WASN'T EMPTYING OUT THE POUCH AS OFTEN AS HE SHOULD HAVE. PRODUCT SPECIALIST EXPLAINED TO EMPTY THE POUCH WHEN IT WAS 3/4 FULL. PATIENT STATED HE WAS NOT DOING THAT. PATIENT STATED HE ENDED UP IN THE HOSPITAL WITH A UTI, WHICH TURNED INTO SEPSIS. PATIENT STATED HE IS CURRENTLY IN THE HOSPITAL AND BEING DISCHARGED TOMORROW. PATIENT IS AT THE (B)(6) HOSPITAL. PATIENT WAS UNABLE TO PROVIDE THE MEN'S LIBERTY LOT NUMBER.

  Patient problems: Urinary Tract Infection

  MAUDE report 17975392 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S WIFE REPORTED HER HUSBAND WAS HOSPITALIZED WITH UTI WHILE USING MEN'S LIBERTY. SHE STATED THE WEIGHT OF THE BAG WAS PULLING ON HIM AND NOT DRAINING INTO THE BED BAG. SHE STATED THEY ONLY USED MEN'S LIBERTY 3 TIMES. PATIENT'S WIFE STATED THIS IS THE FIRST TIME HE HAS HAD A UTI. PRODUCT SPECIALIST FOLLOWED UP WITH THE PATIENT'S WIFE THE NEXT DAY. PATIENT'S WIFE STATED HE SLEEPS MOSTLY ON HIS BACK, HARDLY TURNS, AND WEARS BRIEFS. SHE ALSO MENTIONED FINDING THE ML BAG STUCK UNDER HIS LEG. PRODUCT SPECIALIST EXPLAINED PROPER POSITIONING, HOW THAT AFFECTS URINE FLOW AWAY FROM THE ANATOMY WITH GRAVITY, AND THAT AN OBSTRUCTION COULD CAUSE URINE TO BACK UP. PATIENT'S WIFE STATED HE WAS TREATED WITH CIPRO ANTIBIOTICS, BUT HIS CONDITION WORSENED. SHE STATED HE EXPERIENCED SHAKING, LOSING CONSCIOUSNESS, AND AN ALTERED MENTAL STATE. SHE STATED HE WAS THEN HOSPITALIZED TO RECEIVE IV ANTIBIOTICS. PATIENT'S WIFE CALLED BACK IN ON (B)(6) 2022 TO REPORT HE WAS HOME AND DOING BETTER, BUT SHE IS NOT USING THE PRODUCT ANYMORE.

  Patient problems: Urinary Tract Infection

  MAUDE report 14950206 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S WIFE REPORTED THE PATIENT HAS HAD TWO UTIS SINCE HE STARTED TO USE MEN'S LIBERTY EXTERNAL CATHETER IN (B)(6) 2021. PATIENT'S WIFE STATED HE WAS HOSPITALIZED FOR BOTH INFECTIONS AND IS IN A REHAB CENTER NOW. PATIENT'S WIFE STATED HE HAS BEEN CLEARED OF THE INFECTION BY HIS DOCTOR, IS STILL TAKING ANTIBIOTICS, AND IS STILL USING MEN'S LIBERTY. PRODUCT SPECIALIST WENT OVER THE APPLICATION STEPS AND EXPLAINED PROPER POSITIONING OF THE DEVICE TO ALLOW URINE TO FLOW AWAY FROM THE ANATOMY WITH GRAVITY. PATIENT OR PATIENT'S WIFE DID NOT REPORT THIS TO BIODERM PREVIOUSLY.

  Patient problems: Urinary Tract Infection

  MAUDE report 14856110 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S WIFE CALLED IN ASKING ABOUT BIOPLUS+ WIPES STATING THE PATIENT HAS BLISTERS AT THE HEAD OF HIS PENIS AFTER MEN'S LIBERTY IS REMOVED. PRODUCT SPECIALIST EXPLAINED THEY SHOULD STOP USE UNTIL HE IS HEALED AND EXPLAINED HOW TO PERFORM AN ALLERGY TEST. PATIENT'S WIFE ALSO STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR UTI WHILE USING MEN'S LIBERTY. SHE STATED HE WAS TREATED WITH CEPHALEXIN 500MG AND THAT HIS DOCTOR STATED HE COULD CONTINUE USING MEN'S LIBERTY. PRODUCT SPECIALIST EXPLAINED HE SHOULD WAIT UNTIL CLEARED OF INFECTION BEFORE CONTINUING USE. PATIENT'S WIFE STATED IT WAS THREE YEARS SINCE HIS LAST UTI. PRODUCT SPECIALIST WENT OVER THE APPLICATION INSTRUCTIONS AND PRODUCT USE. PATIENT'S WIFE EXPLAINED SHE USES A PERINEAL CLEANER, SHE USES OTHER CLEANSERS, HE LEAKS DURING APPLICATION, SHE WON'T USE A PENILE CLAMP DURING APPLICATION TO STOP THE LEAKING, HE ONLY USES MEN'S LIBERTY DURING THE DAY, HE IS IN A RECLINER DURING THE DAY, AND HE HAS RETRACTION. PRODUCT SPECIALIST EXPLAINED PROPER POSITIONING TO ALLOW URINE TO FLOW AWAY FROM THE ANATOMY WITH GRAVITY AND HOW TO AVOID SUCTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 14737514 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS CONTACTED FOR PRODUCT USE FOLLOW UP. HE STATED HE CURRENTLY HAS A UTI WHILE USING MEN'S LIBERTY AND IS HOSPITALIZED DUE TO THE INFECTION. PATIENT STATED HE HAS A HISTORY OF UTI, AND THIS IS THE THIRD UTI. PATIENT STATED HE WAS TREATED WITH CIPRO AND OTHER ANTIBIOTIC FOR AN UNRELATED ISSUE. BIODERM PRODUCT SPECIALIST WENT OVER THE APPLICATION STEPS AND PRODUCT USE INSTRUCTIONS. PATIENT STATED HE WAS USING ADULT DIAPERS WITH MEN'S LIBERTY. THE PRODUCT SPECIALIST EXPLAINED THE RECOMMENDED UNDERWEAR AND WHEN TO DRAIN AND EMPTY THE MEN'S LIBERTY URINE COLLECTION POUCH. PATIENT STATED HE WILL RESUME USE OF MEN'S LIBERTY WHEN HIS ANTIBIOTICS ARE COMPLETE.

  Patient problems: Urinary Tract Infection

  MAUDE report 14700102 ↗