Natural™ Non-Adhesive Male External Catheter 38301Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741071225), received between Sep 2, 2020 and Jul 20, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ALLERGIC TO LATEX AND ADHESIVE 25 MILLIMETER MALE EXTERNAL CATHETERS WERE CAUSING THE PATIENT TO HAVE URINARY TRACT INFECTIONS AND THE ANTIBIOTICS WERE CAUSING OTHER ISSUES. THE PATIENT HAD TO CONTACT THEIR LAWYERS TO GET MANAGEMENT INVOLVED THEY DID NOT UNDERSTAND WHY THEY HAD SUCH AND ISSUE EXPLAINED THERE WERE MULTIPLE REASON AND WAS TAKES TIME TO PRODUCE A CATHETER. THE PATIENT WAS NOT SURE WHAT THEY WOULD NEED TO DO. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 15067394 ↗
• MalfunctionMay 26, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE NURSE WAS TRYING TO WARM A 10 MONTH OLD PATIENT FROM 35C TO 36C USING THE ARCTIC SUN DEVICE BUT THE PATIENT WAS NOT WARMING. THE WATER WAS NOT GETTING ANY WARMER EITHER. DEVICE WAS GIVING ALERT 113 (REDUCED WATER TEMPERATURE CONTROL) AND THE DEVICE WAS CURRENTLY STOPPED. NURSE RESUMED THERAPY, FLOW RATE WAS 0.6 LPM AND PAD LOT NUMBER WAS NGFU2455 (PRODUCT CODE 31700). MSS EXPLAINED THAT THIS WAS A UNIVERSAL PAD USED FOR ADULT PATIENTS TO COVER EXPOSED ABDOMEN. MSS SUGGESTED GETTING SMALL UNIVERSAL PAD(S) OR ANOTHER UNIVERSAL PAD, IF THERE WAS NOT ENOUGH ROOM ON THE PATIENT TO ADD ANOTHER PAD AND PLACE IT TO THE SIDE. MSS STATED THAT THE FLOW RATE WAS TOO LOW FOR THE HEATER TO WORK APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516472 ↗
• MalfunctionMay 6, 2022Expiration Date Error; Device Handling Problem; Expiration Date Error; Device Handling Problem

  IT WAS REPORTED THAT SMALL SET OF ARCTIC GEL PADS WERE OPENED AND GEL CAME OFF FROM THE PAD RENDERING IT UNUSABLE. NURSE REPLACED WITH UNIVERSAL PAD FOR THERAPY. NURSE NOTICED PETECHIAE ON SKIN UNDER PADS AFTER REMOVAL. THE NURSE NOTED THAT THE UNIVERSAL PADS WERE EXPIRED BUT UNABLE TO CONFIRM EXPIRATION DATE OF THE PADS USED. MULTIPLE ADJUSTMENTS WERE MADE TO DEVICE DURING THERAPY. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 14APR2022, THE LOT NUMBER WAS NGEN0469. THE PETECHIA WAS FOUND ACROSS THE PATIENT ABDOMINAL AREA. THE SKIN CONDITION BEFORE PADS WERE APPLIED WAS CLEAR WITH NO ISSUES. THE THERAPY WAS STOPPED INTO 7 HOURS OF REWARMING PHASE. NO MEDICAL INTERVENTION WAS TAKEN, THE PADS WERE REMOVED FROM PATIENT AND THEY CONTINUED TO MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309642 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE STRAP THAT HELD THE MALE EXTERNAL CATHETER ON DID NOT LAST FOR A FULL 10 DAYS. PATIENT ONLY GOT 7 DAYS OUT OF THEM. REPRESENTATIVE STATED THAT IF THE PATIENT USED THEM FOR THE FULL 10 DAYS THE PATIENT MIGHT GET URINARY TRACT INFECTION (UTI). PER FOLLOW UP INFORMATION RESPONSE RECEIVED VIA PHONE ON (B)(6) 2022, REPORTED THAT THE PATIENT HAD A LATEX AND ADHESIVE ALLERGY. ALSO REPORTED THAT THE PATIENT HAD 3 SEVERE UTI¿S (URINARY TRACT INFECTION) IN THE LAST FEW MONTHS AND WAS TREATED BY DOCTOR WITH ANTIBIOTICS. REPRESENTATIVE ALSO STATED THAT NEEDED MORE STRAPS EACH MONTH FOR THE MALE EXTERNAL CATHETER. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME.

  Patient problems: Urinary Tract Infection

  MAUDE report 14309609 ↗
• InjuryMar 2, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE STRAP THAT HOLDS THE MALE EXTERNAL CATHETER ON DID NOT LAST FOR A FULL 10 DAYS. PATIENT ONLY GOT 7 DAYS OUT OF THEM. REPRESENTATIVE STATED THAT IF THE PATIENT USES THEM FOR THE FULL 10 DAYS THE PATIENT GETS URINARY TRACT INFECTION (UTI). IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Hypersensitivity/Allergic reaction; Urinary Tract Infection

  MAUDE report 13653479 ↗
• MalfunctionSep 2, 2020Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT STATED THE NATURALS KEEP FALLING OFF USING THE SMALLEST SIZE. THE PATIENT HAD SOME RETRACTION. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10483786 ↗