MAUDE Adverse Event Report: SYRINGE/ADAPTER; DISPENSER, LIQUID MEDICATION

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

No issue with medication, product complaint is for syringes/adapters - patient's mother states new style adapter does not fit properly into the bottle and continues to pop out.No missed doses or adverse events.Unknown if patient has defective syringes/adapters on hand.No additional information known.Product lot number is unknown.Indication: other generalized epilepsy and epileptic syndromes, intractable, without status epilepticus.Reported to (b)(6) by pt/caregiver.

• Brand Name: SYRINGE/ADAPTER
• Type of Device: DISPENSER, LIQUID MEDICATION
• MDR Report Key: 16573955
• MDR Text Key: 311701402
• Report Number: MW5115845
• 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: 03/15/2023

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?: Yes
• Device Expiration Date: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2023
• Patient Sequence Number: 1
• Treatment: EPIDIOLEX ORAL SYR 5ML, STRENGTH- 1429VA0047
• Patient Sex: Female