MAUDE Adverse Event Report: MERCK SHARP & DOHME CORP. WILSON DULERA INHALER (DEVICE); NASAL SPRAY, ENT DELIVERY (KCO)

Lot Number W022923

Device Problems Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Asthma (1726)

Event Type  malfunction  

Event Description

Nothing comes out when pressing on the pump.Counter stuck on 120.[device malfunction].Nothing comes out when pressing on the pump.Counter stuck on 120.[poor quality device used].Patient missed her dose [product dose omission issue].Case narrative: this spontaneous report was received via dpoc from a pharmacist referring to a 53-year-old female patient.The patient's medical history, concurrent conditions, concomitant medications, and drug reactions/allergies were not reported.On (b)(6) 2022, the patient started therapy with mometasone furoate (+) formoterol fumarate (zenhale) strength 200 micrograms (mcg) (dose, frequency, and route not reported; lot # w022923, and expiration date reported as 06-sep-2023 for asthma.On (b)(6) 2022, while using the inhaler, it was reported that nothing came out when pressing on the pump and the counter stuck on 120 (device malfunction; poor quality device used) and the patient missed her dose (product dose omission issue).The format was 120 doses on the inhaler.The unit did not ever spray from the first use.The dust cap was removed and primed before spraying and there was not anything blocking the mouthpiece.The unit did not spray from when it was first received, and the counter was not counting down with each dose.It had not been more than 5 days since the unit was last used.The counter was currently showing 120 doses.The inhaler was available for return.Additional information is not expected.

• Brand Name: DULERA INHALER (DEVICE)
• Type of Device: NASAL SPRAY, ENT DELIVERY (KCO)
• Manufacturer (Section D): MERCK SHARP & DOHME CORP. WILSON; 4633 merck road; wilson NC 27893
• Manufacturer (Section G): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 16059802
• MDR Text Key: 308241663
• Report Number: 1036761-2022-00009
• Device Sequence Number: 1
• Product Code: KCO
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2023
• Device Lot Number: W022923
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female