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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FOLEY CATHETER Back to Search Results
Device Problem Biocompatibility (2886)
Patient Problem Pressure Sores (2326)
Event Date 12/13/2021
Event Type  Injury  
Event Description
It was reported that customer received reports of foley pressure injuries primarily on the penile tip and the skin under statlocks.It was unknown what medical intervention was provided for pressure injuries.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be mechanical failure, operator error, user hypersensitivity to latex, bacterial infection.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.Correction: h.H11: 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.
 
Event Description
It was reported that customer received reports of foley pressure injuries primarily on the penile tip and the skin under statlocks.It was unknown what medical intervention was provided for pressure injuries.
 
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Brand Name
UNKNOWN FOLEY CATHETER
Type of Device
UNKNOWN FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13088295
MDR Text Key285185947
Report Number1018233-2021-08440
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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