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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SILI UMST TR

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MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SILI UMST TR Back to Search Results
Catalog Number URO170816S
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2019
Event Type  malfunction  
Manufacturer Narrative
It was initially reported that the patient's foley catheter had "fallen out again." this foley catheter was placed in the emergency department as replacement for a foley catheter that "fell out." the foley catheter's balloon was reportedly leaking.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.Due to the reported event and required foley catheter exchange, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
 
Event Description
It was reported that the patient's foley catheter had "fallen out again.".
 
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Type of Device
TTL1LYR 16FR10ML 100%SILI UMST TR
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
bermon punzalan
three lakes drive
northfield, IL 60093
MDR Report Key8739843
MDR Text Key150277084
Report Number1417592-2019-00102
Device Sequence Number1
Product Code OHR
UDI-Device Identifier10889942126828
UDI-Public10889942126828
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/27/2019
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? Yes
Device Operator Health Professional
Device Catalogue NumberURO170816S
Device Lot Number592180606
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/30/2019
Initial Date FDA Received06/27/2019
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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