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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRECISE DOSE DISPENSER; DISPENSER, LIQUID MEDICATION

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PRECISE DOSE DISPENSER; DISPENSER, LIQUID MEDICATION Back to Search Results
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Description
Our hospital recently purchased l.E.T.(lidocaine, epinephrine, and tetracaine) topical gel that is compounded by quva pharma.This product is used in our pediatric emergency department, and would take the place of our own pharmacy's compounded product.The pharmacist who ordered this noticed that the syringe it is dispensed in, precise dose dispenser, is used for both oral and topical products.The label does state for external use only, but it is in very small letters.We are concerned that this could easily be confused with an oral medication.(b)(4).
 
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Brand Name
PRECISE DOSE DISPENSER
Type of Device
DISPENSER, LIQUID MEDICATION
MDR Report Key16462142
MDR Text Key310635169
Report NumberMW5115350
Device Sequence Number1
Product Code KYX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/28/2023
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? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/28/2023
Patient Sequence Number1
Treatment
LIDOCAINE-EPINEPHRINE-TETRACAINE (LET) GEL - TOPICAL, SYRINGE, PRECISE DOSE DISPENSER, MFR: QUVA PHARMA INC.,
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