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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY,FOLEY 100% SILI 18FR 10ML
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MEDLINE INDUSTRIES, LP; TRAY,FOLEY 100% SILI 18FR 10ML Back to Search Results
Catalog Number DYND11528H
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/21/2023
Event Type  Injury  
Event Description
According to the facility the foley catheter balloon failed requiring the catheter to be replaced.
 
Manufacturer Narrative
According to the facility the foley catheter balloon failed requiring the catheter to be replaced.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
TRAY,FOLEY 100% SILI 18FR 10ML
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key18274719
MDR Text Key329837569
Report Number1417592-2023-00488
Device Sequence Number1
Product Code OHR
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 12/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberDYND11528H
Was Device Available for Evaluation? No
Date Manufacturer Received11/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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