Incontinence Clamp 004054Recalls & reported problems

C. R. Bard, Inc. · Cunningham Incontinence Clamp, Large · Class 1

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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741072765), received between Oct 30, 2017 and May 6, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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

Device problems

Component Missing1
Device Markings/Labelling Problem1
Patient Device Interaction Problem1
Patient-Device Incompatibility1

Patient problems

Burning Sensation1
Erythema1
No Code Available1
No Consequences Or Impact To Patient1
No Known Impact Or Consequence To Patient1
Peeling1
Skin Inflammation/ Irritation1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryMay 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE CUNNINGHAM CLAMP RUBBED A SPOT ONTO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP RECEIVED ON 11APR2022, IT WAS STATED THAT THE CUNNINGHAM CLAMP RUBBED A SORE ON THE SHAFT. IT WAS STATED THAT THERE WOUND WAS THERE FOR 3 WEEKS. THIS WAS THE SECOND TIME THAT THIS HAD HAPPENED. DOCTOR PRESCRIBED MEDICATION FOR THE WOUND AND ADVISED CUSTOMER TO PAD THE PATIENT PENIS WITH GAUZE TO HELP WITH CHAFING. CUSTOMER WAS ALSO SENT A LARGER SIZE WITH THE SAME RESULTS .
Patient problems: Skin Inflammation/ Irritation
MAUDE report 14310738 ↗
MalfunctionDec 19, 2018Component Missing; Component Missing; Device Markings/Labelling Problem
IT WAS REPORTED THAT THERE WERE NO INSTRUCTIONS WITH THE CUNNINGHAM CLAMP.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8178468 ↗
InjuryOct 30, 2017Patient-Device Incompatibility
IT WAS REPORTED THAT AS A RESULT OF USAGE OF OUR DEVICE, THE PATIENT EXPERIENCED RED RAW SKIN THAT PEALED OFF, A BURNING SENSATION, AND A BOIL. ALLEGEDLY, THE PATIENT SAW HIS PHYSICIAN, WHO MADE AN INCISION TO REMOVE WHAT WAS INSIDE THE BOIL AND PACKED THE BOIL. THE BOIL WAS ALLEGEDLY 1 INCH LONG BY 1/2 INCH WIDE. THE PATIENT ALLEGEDLY HAD A SCAB THAT FORMED OVER THE INCISION. THE PHYSICIAN DID NOT PRESCRIBE ANY MEDICATION AND ADVISED THE PATIENT TO STOP USING THE CUNNINGHAM CLAMP.
Patient problems: Burning Sensation; Erythema; No Code Available; Peeling
MAUDE report 6988664 ↗

Device details

UDI-DI	`00801741072765`
Brand	Incontinence Clamp
Model	004054
Company	C. R. Bard, Inc.
Product code	FHA · CLAMP, PENILE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 14, 2020

Device type (GMDN): Incontinence penis clamp, reusable

A male urinary incontinence device designed to gently compress the penis, either the proximal shaft or the glans penis, to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder. It is typically made of plastic materials and is designed as an adjustable, two-hinged, self-retaining lever clamp with foam rubber inserts; the user can typically adjust the tension to suit their penis size and needs. It is removed by the user when voiding and then reapplied. The device is washed/disinfected at regular intervals to maintain hygiene. This is a reusable device.

Other CLAMP, PENILE devices

Incontinence Clamp 004053
C. R. Bard, Inc. · CLAMP, PENILE
12 reports

All CLAMP, PENILE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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