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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; MEC
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C.R. BARD, INC. (COVINGTON) -1018233 MALE EXTERNAL CATHETER; MEC Back to Search Results
Device Problems Nonstandard Device (1420); Defective Device (2588)
Patient Problems Abrasion (1689); Erythema (1840); Tissue Damage (2104); Skin Tears (2516)
Event Date 03/19/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the catheters adhesive was too strong and caused skin tears.The complainant alleged upon removal of the condom catheter, the nurse noted redness and wound to patient's posterior shaft of penis.The nurse placed wound consult as well as paged the primary neu team to make the patient aware of injury to penis.The patient denied any pain at site.The wound care evaluated and determined injury to be from condom catheter pressure.The facility was unsure if it was a bard product.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.A labeling review was not required since the product code was unknown.Therefore, bd was unable to determine the associated labeling to review.Although the product code is unknown, the intermittent catheter labeling was found to be adequate based on past reviews.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.H3 other text : the device was not returned.
 
Event Description
It was reported that the catheters adhesive was too strong and caused skin tears.The complainant alleged upon removal of the condom catheter, the nurse noted redness and wound to patient's posterior shaft of penis.The nurse placed wound consult as well as paged the primary neu team to make the patient aware of injury to penis.The patient denied any pain at site.The wound care evaluated and determined injury to be from condom catheter pressure.The facility was unsure if it was a bard product.
 
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Brand Name
MALE EXTERNAL CATHETER
Type of Device
MEC
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8718265
MDR Text Key149071048
Report Number1018233-2019-03255
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 company representative,other
Type of Report Initial,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received06/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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