MAUDE Adverse Event Report: LUPIN PHARMACEUTICALS INC. INHALER; NASAL SPRAY, ENT DELIVERY

Lot Number	IA00269
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A reporter called to submit a report about the defective inhalers he is using from lupin.He said he has been using inhalers for so long for his asthma, but the lupin inhalers do not work.He said when he depresses the equipment nothing comes out.He said he almost died last night from asthma attack because the inhaler did not work.He said at least 10 of them failed.Reference reports: #mw5158133, #mw5158134, #mw5158135, #mw5158136, #mw5158137, #mw5158138, #mw5158139, #mw5158140, #mw5158141.

• Brand Name: INHALER
• Common Device Name: NASAL SPRAY, ENT DELIVERY
• Manufacturer (Section D): LUPIN PHARMACEUTICALS INC.; harborplace tower,111 s. calvert street; 21st floor; baltimore MD 21202
• MDR Report Key: 19938864
• Report Number: MW5158142
• Device Sequence Number: 8758683
• Product Code: KCO
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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 Expiration Date: 02/28/2026
• Device Lot Number: IA00269
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male