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

Lot Number W000232

Device Problems Product Quality Problem (1506); Device Displays Incorrect Message (2591)

Patient Problem Asthma (1726)

Event Type  malfunction  

Event Description

Patient's asthma condition worsened [asthma].Counter jumped down from 64 to 0 [device malfunction].Counter jumped down from 64 to 0 [poor quality device used].Counter jumped down from 64 to 0 [device malfunction].Counter jumped down from 64 to 0 [poor quality device used].Case narrative: this spontaneous report was received from a consumer via dpoc referring to a 61-year-old female patient.The patient's medical history, concomitant medications, and drug reactions/allergies were not reported.The patient's concurrent condition included asthma.On an unknown date, the patient started therapy with mometasone furoate (+) formoterol fumarate (zenhale)#1, 200 microgram (mcg) strength (dose, frequency, and route were not reported; lot # w000232 expiration date reported as 07-jul-2023) for asthma.On an unknown date, the patient started therapy with the second mometasone furoate (+) formoterol fumarate (zenhale)#2, 200 mcg strength (dose, frequency, and route were not reported; lot # w020671 has been validated to be a valid lot number for mometasone furoate (+) formoterol fumarate, with expiration date 20-jul-2023) for asthma.On an unknown date, the counter jumped down from 64 to 0 (device malfunction; poor quality device used; device malfunction, poor quality device used) (the same description was reported for both the units of inhalers).On an unknown date, the patient's asthma condition worsened (asthma).It was reported that the patient had removed the dust cap before spraying, and the number on the counters was 120 when the patient initially used the device.However, during use, the dose counters had skipped numbers and was now reading 0 (misaligned).Both the devices were available to return to the manufacturer.Additional information is not expected.Action taken with both the inhalers with respect to the event asthma was not reported.The outcome of asthma was unknown.The reporter's causality assessment was not provided.

• 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: 16047254
• MDR Text Key: 308355185
• Report Number: 1036761-2022-00007
• Device Sequence Number: 1
• Product Code: KCO
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2022

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: 07/07/2023
• Device Lot Number: W000232
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2022
• 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: 61 YR
• Patient Sex: Female