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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. STENTUBE LACRIMAL INTUBATION SET
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QUEST MEDICAL, INC. STENTUBE LACRIMAL INTUBATION SET Back to Search Results
Model Number LIS052
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/23/2017
Type of Reportable Event Serious Injury
Event or Problem Description
The surgery center reported an issue with the stentube lacrimal intubation device during use.The surgeon reported that of three (3) devices they used, they "just fell apart" during use.There was no additional details provided other than they were from the same lot.There were no patient complications reported as a result of the alleged issue.The actual devices were not returned for evaluation; however, one remaining device from the same lot was returned to the manufacturer.
 
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Brand Name
STENTUBE LACRIMAL INTUBATION SET
Common Device Name
LACRIMAL INTUBATION SET
Manufacturer (Section D)
QUEST MEDICAL, INC.
one allentown parkway
allen TX 75002
MDR Report Key6656085
Report Number1649914-2017-00049
Device Sequence Number1150555
Product Code OKS
UDI-Device Identifier10634624815527
UDI-Public10634624815527
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
K113118
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Model NumberLIS052
Device Lot Number052858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/23/2017
Initial Report FDA Received Date06/20/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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