MAUDE Adverse Event Report: ACTAVIS PHARMACEUTICAL COMPANY / TEVA PHARMACEUTICALS USA INHALER; INHALER, METERED DOSE OR DRY POWDER, CDER OR CBER LED

Lot Number 180330

Device Problems Failure to Deliver (2338); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2020

Event Type  No Answer Provided  

Event Description

Reporter said both of his inhalers are defective.They barely deliver his medication.

• Brand Name: INHALER
• Type of Device: INHALER, METERED DOSE OR DRY POWDER, CDER OR CBER LED
• Manufacturer (Section D): ACTAVIS PHARMACEUTICAL COMPANY / TEVA PHARMACEUTICALS USA ; 1090 horsham rd; north wales PA 19454
• MDR Report Key: 10065099
• MDR Text Key: 191402431
• Report Number: MW5094531
• Device Sequence Number: 1
• Product Code: QKS
• UDI-Device Identifier: 0591292754
• UDI-Public: 0591-2927-54
• 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: 05/15/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/20/2020
• Device Lot Number: 180330
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2020
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 73