Incontinence Clamp 004053Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741072758), received between Jul 19, 2017 and Feb 2, 2023 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (3 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

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT LAST WEEKEND WHEN A PATIENT USED THE CUNNINGHAM CLAMP PRODUCT, IT GAVE THEM A LOT OF PRESSURE IN THE URETHRA. WHILE REMOVING, PATIENT CUT THEMSELVES INSIDE THE URETHRA AFTER IT GOT HOOKED IN THERE, IT CAUGHT THE INSIDE OF THEIR URETHRA. THE PATIENT SAID THAT THEY BLEED FOR TWO DAYS AND USED A Q-TIP WITH PETROLEUM JELLY TO HELP STOP THE BLEEDING ON THE SECOND DAY. PATIENT DID CALL THE DOCTOR AND THAT THE DOCTOR WANTED TO SEE THEM, BUT THEY SAID NO BECAUSE THEY HAD AN APT IN (B)(6) 2023. THE PATIENT WAS NO LONGER CLAMPING AT THIS TIME.

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

  MAUDE report 16283059 ↗
• InjuryMay 10, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE CUNNINGHAM CLAMP WOULD NOT OPEN AND CAUSED PATIENT INJURY DUE TO BACKED UP URINE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INJURY.

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

  MAUDE report 14347490 ↗
• MalfunctionJan 31, 2020Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE CUNNINGHAM CLAMP WAS LABELED AS A MEDIUM; HOWEVER, A LARGE PRODUCT WAS INSIDE OF THE PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9652970 ↗
• MalfunctionOct 15, 2019Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE CLAMP WAS TOO SMALL AND HAD NO INSTRUCTIONS FOR USE. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9192338 ↗
• InjuryMay 9, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN HIS SHAFT. HE HAD SWOLLEN AND RED TESTICLES WITH USE OF THE DEVICE. THE CUSTOMER ALLEGED HE WAS SEEN AT URGENT CARE WHERE HE RECEIVED AN ULTRASOUND AND WAS PRESCRIBED ANTIBIOTICS. THE CUSTOMER WILL FOLLOW UP WITH THE UROLOGIST TO DETERMINE IF HE WILL CONTINUE USE IT OR NOT.

  Patient problems: Erythema; Pain; Skin Discoloration; Swelling; Unspecified Infection

  MAUDE report 8594620 ↗
• MalfunctionApr 12, 2019Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUNNINGHAM CLAMP WAS LARGER THAN 2 INCHES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8509362 ↗
• MalfunctionNov 30, 2018Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE THAT BOX DID NOT HAVE CLEAR INSTRUCTIONS ON HOW TO USE THE CLAMP. THE PATIENT EXPERIENCED SOME DISCOMFORT AFTER ONE HOUR OF USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 8119894 ↗
• InjuryAug 27, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENTS' PENIS ALLEGEDLY TURNED RED AND BECAME INFECTED WHILE USING THE CUNNINGHAM CLAMP. THE PATIENT STATED HE WAS PRESCRIBED ANTIBIOTICS AND WAS GIVEN SHOTS AT THE DOCTORS' OFFICE FOR THE DIAGNOSED INFECTION. IT WAS LATER REPORTED VIA PHONE ON (B)(6)2018, THE COMPLAINANT STATED HE WORE THE CLAMP FROM 8AM TO AROUND 5PM WHILE HE WAS AT WORK. THE COMPLAINANT STATED THAT HE DID NOT KNOW WHAT KIND OF INFECTION HE HAD OR WHAT SHOTS OR ANTIBIOTICS HE RECEIVED.

  Patient problems: Skin Discoloration; Unspecified Infection

  MAUDE report 7819795 ↗
• MalfunctionJun 12, 2018Naturally Worn

  IT WAS REPORTED THAT THE RUBBER ON THE CUNNINGHAM CLAMP WAS WORN OUT AND DETERIORATED. THE PATIENT ALLEGEDLY EXPERIENCED DISCOMFORT IN HIS LEG.

  Patient problems: Discomfort

  MAUDE report 7591952 ↗
• MalfunctionMar 19, 2018Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE PATIENT FOUND THE CUNNINGHAM CLAMP INSTRUCTIONS FOR USE NOT COMPREHENSIVE. THE PATIENT REPORTEDLY CAUGHT HIS PUBIC HAIR IN THE DEVICE DURING USE AND ATTEMPTED TO USE SCISSORS TO CUT HIS HAIR FREE. THE PATIENT CUT HIMSELF WITH HIS SCISSORS AND REPORTEDLY EXPERIENCED PAIN AND SELF-LIMITED BLEEDING. THE PATIENT WOULD LIKE THE INSTRUCTIONS TO STATE THAT THE CLAMP SHOULD BE PUT ON WHILE STANDING AND TO BE MINDFUL OF PUBIC HAIR. THE PATIENT STATED THAT NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Patient Problem/Medical Problem

  MAUDE report 7349600 ↗
• InjuryAug 17, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S PENIS TURNED BLUE AND BEGAN TO SWELL SEVERAL MINUTES AFTER APPLICATION. THE PATIENT EXPERIENCED PAIN BUT DID NOT RECEIVE ANY MEDICAL ATTENTION.

  Patient problems: Pain; Skin Discoloration; Swelling

  MAUDE report 6801112 ↗
• MalfunctionJul 19, 2017Disconnection

  IT WAS REPORTED THAT THE PADDING DISCONNECTED FROM THE CLAMP; AS A RESULT, THE CLAMP COULD NOT CLOSE PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6725658 ↗