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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; CATHETER,FOLEY,3WAY,SILI-ELAST,20FR,30ML
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MEDLINE INDUSTRIES INC; CATHETER,FOLEY,3WAY,SILI-ELAST,20FR,30ML Back to Search Results
Catalog Number DYND11802
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 01/22/2024
Event Type  malfunction  
Manufacturer Narrative
According to the customer, a "turp was performed and at the end the 3-way foley catheter was placed, this did not work properly because the return flow is very slow and is not adequate, since it makes bladder balloon.".The customer reported "we ended up opening another catheter".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Event Description
According to the customer, a "turp was performed and at the end the 3-way foley catheter was placed, this did not work properly because the return flow is very slow and is not adequate, since it makes bladder balloon.".
 
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Type of Device
CATHETER,FOLEY,3WAY,SILI-ELAST,20FR,30ML
Manufacturer (Section D)
MEDLINE INDUSTRIES INC
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
alex mathew
three lakes drive
northfield, IL 60093-2753
2249317042
MDR Report Key18727611
MDR Text Key336074309
Report Number1417592-2024-00075
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberDYND11802
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/22/2024
Initial Date FDA Received02/16/2024
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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