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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MALE EXTERNAL CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 MALE EXTERNAL CATHETER Back to Search Results
Device Problems Nonstandard Device (1420); Physical Resistance/Sticking (4012)
Patient Problems Irritation (1941); Skin Irritation (2076)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that some of the male external catheters were sticking too hard to the patient's skin and caused him irritation.No medical intervention was reported.The patient switched to using the natural mec.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿too high viscosity¿ with a potential root cause of ¿viscometer failure or mechanical failure¿.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device was not returned.
 
Event Description
It was reported that some of the male external catheters were sticking too hard to the patient's skin and caused him irritation.No medical intervention was reported.The patient switched to using the natural mec.
 
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Brand Name
MALE EXTERNAL CATHETER
Type of Device
MALE EXTERNAL CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9948911
MDR Text Key187792160
Report Number1018233-2020-02516
Device Sequence Number1
Product Code NNX
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received04/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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