MAUDE Adverse Event Report: LUPIN PHARMACEUTICALS INC. LUPINHALER; NEBULIZER (DIRECT PATIENT INTERFACE)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

Reporter called with complaint that her lupinhaler device is malfunctioning.The device will not deliver medication and it will not open to enable insertion of new capsules (tiotropium bromide powder) for delivery of medication.Additionally, the capsule packaging is extremely difficult to open.

• Brand Name: LUPINHALER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): LUPIN PHARMACEUTICALS INC.
• MDR Report Key: 18447007
• MDR Text Key: 332147342
• Report Number: MW5149792
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• 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: 01/03/2024

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female