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Natural™ Non-Adhesive Male External Catheter 38302Recalls & reported problems

C. R. Bard, Inc. · Natural™ Non-Adhesive Male External Catheter · Class 1

All models of Natural Non-Adhesive Male External Catheter (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741071232), received between Feb 21, 2018 and Dec 14, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (4 reports).

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

Device problems

  • Nonstandard Device4
  • Defective Component1
  • Device Operates Differently Than Expected1
  • Difficult to Fold, Unfold or Collapse1
  • Difficult to Remove1
  • Restricted Flow rate1
  • Therapeutic or Diagnostic Output Failure1

Patient problems

  • No Consequences Or Impact To Patient3
  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient2
  • Abrasion1
  • Cyanosis1
  • Pain1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 14, 2021Nonstandard Device; Nonstandard Device

    IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER ADHESIVE WAS RUBBING AWAY AT THE PATIENT¿S SKIN SO THE PATIENT DIDN¿T LIKE THAT. THE PATIENT HAD BEEN USING THIS PRODUCT FOR LESS THAN 90 DAYS. NO MEDICAL INTERVENTION REPORTED.

    Patient problems: Abrasion; No Clinical Signs, Symptoms or Conditions

    MAUDE report 13002979 ↗
  • MalfunctionOct 31, 2020Restricted Flow rate; Restricted Flow rate

    IT WAS REPORTED THAT THE URINE WAS BACKING UP AND THE MALE EXTERNAL CATHETERS WERE COMING OFF AT NIGHT. LIBERATOR REPRESENTATIVE PROVIDED APPLICATION AND USAGE INSTRUCTIONS FOR THE EXTERNALS AND THE TUBING.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10767506 ↗
  • MalfunctionFeb 13, 2020Nonstandard Device; Difficult to Remove; Defective Component; Nonstandard Device

    IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE ON THE MALE EXTERNAL CATHETER, WHICH RESULTED IN IT MAKING THEM DIFFICULT TO REMOVE. NO MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9706813 ↗
  • MalfunctionMar 19, 2019Nonstandard Device; Therapeutic or Diagnostic Output Failure; Nonstandard Device

    IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG AND THE PATIENT EXPERIENCED PAIN WHEN THE EXTERNAL CATHETER CAME OFF.

    Patient problems: Pain

    MAUDE report 8434458 ↗
  • MalfunctionSep 11, 2018Difficult to Fold, Unfold or Collapse; Nonstandard Device; Nonstandard Device

    IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WOULD NOT UNROLL CORRECTLY.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7865968 ↗
  • MalfunctionFeb 21, 2018Device Operates Differently Than Expected

    IT WAS REPORTED THAT THE CATHETER HAD TOO STRONG OF AN ADHESIVE. THE CATHETER LEFT A BLUE RING AROUND THE PATIENT'S PENIS.

    Patient problems: Cyanosis

    MAUDE report 7287824 ↗

Other DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices

All DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices →

Sources and updates

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