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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,TEMP SENS,8FR 3ML,LF

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MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,TEMP SENS,8FR 3ML,LF Back to Search Results
Catalog Number DYND110508
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/29/2023
Event Type  Injury  
Event Description
According to the facility on 11/29/23 "registered nurse attempted to remove foley (catheter) but noted resistance with about one inch of the catheter still in the urethra".
 
Manufacturer Narrative
According to the facility on 11/29/23 "registered nurse attempted to remove foley (catheter) but noted resistance with about one inch of the catheter still in the urethra".Per the facility "morphine had to be administered due to the pain".Per facility "balloon noted to be folded on itself creating a ridge".No additional information is available.The sample was requested for evaluation.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.
 
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Type of Device
CATHETER,FOLEY,TEMP SENS,8FR 3ML,LF
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key18419465
MDR Text Key331615487
Report Number1417592-2023-00528
Device Sequence Number1
Product Code EZL
UDI-Device Identifier10884389122990
UDI-Public10884389122990
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 12/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberDYND110508
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2023
Initial Date Manufacturer Received 12/01/2023
Initial Date FDA Received12/29/2023
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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