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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TTL1LYR 16FR10ML 100%SIL TMP TRAY

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MEDLINE INDUSTRIES, LP; TTL1LYR 16FR10ML 100%SIL TMP TRAY Back to Search Results
Catalog Number URO170816T
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/01/2023
Event Type  Injury  
Manufacturer Narrative
According to the facility the foley catheter balloon had a leak requiring the facility to replace the catheter.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.
 
Event Description
According to the facility the foley catheter balloon had a leak requiring the facility to replace the catheter.
 
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Type of Device
TTL1LYR 16FR10ML 100%SIL TMP TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key18229136
MDR Text Key329263930
Report Number1417592-2023-00469
Device Sequence Number1
Product Code OHR
UDI-Device Identifier10888277866942
UDI-Public10888277866942
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 11/29/2023
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 NumberURO170816T
Device Lot Number22LBM415
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2023
Initial Date Manufacturer Received 11/01/2023
Initial Date FDA Received11/29/2023
Was Device Evaluated by Manufacturer? Yes
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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