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

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).

• Brand Name: PRECISE DOSE DISPENSER
• Type of Device: DISPENSER, LIQUID MEDICATION
• MDR Report Key: 16462142
• MDR Text Key: 310635169
• Report Number: MW5115350
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: LIDOCAINE-EPINEPHRINE-TETRACAINE (LET) GEL - TOPICAL, SYRINGE, PRECISE DOSE DISPENSER, MFR: QUVA PHARMA INC.,