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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYRTR 16FR10MLC100%SIL UM SNP

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MEDLINE INDUSTRIES, LP; 1LYRTR 16FR10MLC100%SIL UM SNP Back to Search Results
Catalog Number URO175816C
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/14/2024
Event Type  Injury  
Event Description
According to the facility on (b)(6) 2014 "the foley catheter balloon ruptured and fell out of the patient".
 
Manufacturer Narrative
According to the facility on (b)(6) 2014 "the foley catheter balloon ruptured and fell out of the patient".Per the facility the ballon was not tested prior to insertion and 10cc's of fluid were used to inflate the balloon.Per the facility the catheter was replaced when this occurred, and the patient experienced "irritation and pain".No additional information is available at this time.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
1LYRTR 16FR10MLC100%SIL UM SNP
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key18684976
MDR Text Key335196943
Report Number1417592-2024-00064
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 02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberURO175816C
Device Lot Number23FBE405
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2024
Date Manufacturer Received01/16/2024
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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