Natural Non-Adhesive Male External CatheterRecalls & reported problems across all models

We found 5 models of Natural Non-Adhesive Male External Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Nov 3, 2017 and Feb 15, 2023 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Natural Non-Adhesive Male External Catheter problems

Natural Non-Adhesive Male External Catheter models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Natural™ Non-Adhesive Male External Catheter 38301

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  6 reports
• Natural™ Non-Adhesive Male External Catheter 38302

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  6 reports
• Natural™ Non-Adhesive Male External Catheter 38303

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  6 reports
• Natural™ Non-Adhesive Male External Catheter 38304

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  3 reports
• Natural™ Non-Adhesive Male External Catheter 38305

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  1 report

Recent Natural Non-Adhesive Male External Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT HAD TO PINCH AND PULL THE MALE EXTERNAL CATHETER OFF AND WHICH NOW HAD CAUSED A GROWTH ON THE END OF HIS PENIS. NO MEDICAL ATTENTION REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16378434 ↗
• 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 ↗
• MalfunctionApr 26, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE HARD TO REMOVE, SOMETIMES IT GOT TIGHT ON THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14205300 ↗
• 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 ↗
• MalfunctionDec 29, 2021Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE INSTRUCTIONS FOR USE OF MALE EXTERNAL CATHETERS WERE NOT CLEAR. THE PATIENT HAD BEEN USING THE PRODUCTS FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114985 ↗
• 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 ↗
• MalfunctionApr 27, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE CUSTOMER HAD EXPERIENCED HEMORRHAGE USING MALE EXTERNAL CATHETER. NO MEDICAL INTERVENTION WAS REPORTED. PER A RETURN CALL FROM THE CUSTOMER ON 01APR2021 THE CUSTOMER ALLEGED THE PROBLEM WAS DUE TO RECEIVING THE INCORRECT INFORMATION REGARDING THE MALE EXTERNAL CATHETERS AND THIS EXACERBATED A PRIOR CONDITION AND REQUIRED THE SURGERY. THE CUSTOMER WAS DISCHARGED FROM THE HOSPITAL AFTER HAVING THE SURGERY. THE CUSTOMER DESCRIBED THAT THEY DID NOT KNOW WHAT SIZE OF THE MALE EXTERNAL CATHETER TO ORDER SO CALLED THE REPRESENTATIVE. ALSO THE PATIENT HAD A QUESTION ABOUT HOW TO MEASURE AND KNOW WHAT SIZE OF THE MALE EXTERNAL CATHETER TO ORDER. THE LIBERATOR EMAILED A DOCUMENT TO USE FOR THE MEASUREMENT WITH NO INSTRUCTIONS. ALSO STATED THAT THE MEASUREMENT DEPENDS ON THE PRODUCT BUT MEASURE THE SHAFT. THE PATIENT PLACED AN ORDER BUT DEFINITELY ORDERED THE WRONG SIZE. ALSO STATED THAT THE PATIENT HAD TO STUFF THE HEAD IN AND IT WAS TIGHT AS ALL GET OUT. THERE WAS A BARD MEASURING DEVICE IN THE BOX BUT NO INSTRUCTIONS. THE PATIENT CALLED THE NUMBER INSIDE THE BOX TO ASK AGAIN ABOUT THE MEASUREMENT. THE PATIENT WAS TOLD IT DEPENDS ON THE PRODUCT. THE PATIENT WEARS TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11731903 ↗
• MalfunctionFeb 16, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT WHEN TRYING TO REMOVE AN ADHESIVE MALE EXTERNAL CATHETER, IT ALLEGEDLY CAUSED A TEAR IN PATIENT'S SKIN. IT WAS REPORTED THAT SOMETIMES THE PRODUCT WAS LARGER THAN IT SHOULD BE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Tears

  MAUDE report 11333942 ↗
• InjuryJan 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT WAS USING MALE EXTERNAL CATHETER WITHOUT ADHESIVE AND VELCRO STRAP SIZE 32MM. ALSO, THE DEVICE KEPT CRIMPING UP WHEN USING, WHICH RESULTED IN URINE LEAK AND EVEN BLOOD. THE PATIENT HAD TO GO TO THE EMERGENCE DEPARTMENT AND THE DOCTOR TOLD THAT THE PATIENT DID NOT TURN MUCH AT ALL AND THE CRIMPING WAS A RESPONSE TO HEAT AND THE CATHETER WELDED CLOSED. PER FOLLOW UP RESPONSE RECEIVED VIA PHONE ON 21DEC2020, THE CATHETER GOT TWISTED TO THE POINT WHERE IT DID NOT DRAIN AND THE URINE BACKED UP IN PATIENT'S BLADDER, WHICH RESULTED IN BLEEDING AND CAUSED BLOOD CLOTS AND THEN PREVENTED THE PATIENT FROM VOIDING. THE CUSTOMER REPORTEDLY ENDED UP IN THE EMERGENCY ROOM AS A RESULT, WHERE A 3 WAY FOLEY CATHETER WAS PLACED PURGE THE BLADDER AND THE PATIENT WAS RELEASED. ALSO, THE CUSTOMER RECOMMENDED CHANGING THE COLOR OF THE PACKAGING WITH THE VELCRO BAND BECAUSE THEY WERE DIFFICULT TO LOCATE WITH THE CURRENT COLOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11142263 ↗
• MalfunctionJan 6, 2021Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE LAST BOX OF THE CONDOM CATHETERS HAD ADHESIVE ON THEM, WHICH THEY WERE SUPPOSED TO BE NON-ADHESIVE.

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

  MAUDE report 11124197 ↗
• 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 ↗
• 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 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports