MAUDE Adverse Event Report: UNKINHALER; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Defective Device (2588)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 07/31/2021

Event Type  Injury  

Event Description

Pt states receiving 3 inhalers at once that were different to her usual proair brand and notes that the products were defective.Pt reports that upon getting home she noticed that the albuterol from the first inhaler was not dispensing at all.Pt reports that the second inhaler stopped dispensing after 80 metered inhalations even though it was set for 200 doses.Pt notes that she is barely able use the third inhaler as it dispenses some albuterol but is scared to continue use because she believes it will stop working as well.Pt reports trouble breathing as a result of her incapability to use the inhalers.Pt also states that while using the proair inhaler, she could continue her daily tasks but now with these new inhalers she has to be sedentary.Pt reports concern with the inconvenience of contacting her insurance, following up with her dr in order to obtain a new inhaler prescriptions specifically for the proair inhaler and having to pay out of pocket to replace the inhalers.Of note, pt states displeasure with her pharmacy experience with the technician who gave her the prescriptions and feels that she was misled after being told her insurance no longer covered the proair only to find out that it does.Pt reports that she believes the pharmacy was pushing this brand of inhaler in an attempt to get rid of faulty device.Pt reports that she has encountered several complaints with this brand of inhaler through researching the device.

• Brand Name: UNKINHALER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 12359853
• MDR Text Key: 268213247
• Report Number: MW5103465
• Device Sequence Number: 2
• Product Code: CAF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/23/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR