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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); Appropriate Term/Code Not Available (3191)
Patient Problems Inflammation (1932); No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.The device was not returned.
 
Event Description
It was reported that the adhesive from the male external remained on the patient's skin for three weeks after the removal of the external catheter.The patient also experienced skin inflammation.No medical intervention was required.
 
Event Description
It was reported that the adhesive from the male external remained on the patient's skin for three weeks after the removal of the external catheter.The patient also experienced skin inflammation.No medical intervention was required.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product family for this male external catheter product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the male external catheter product ifus are found to be adequate based on past reviews.Section a through f - the information provided by bard 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 bard.
 
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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 Key7923220
MDR Text Key122457503
Report Number1018233-2018-04479
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 other,user facility
Type of Report Initial,Followup
Report Date 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2018
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 Received10/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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