MAUDE Adverse Event Report: GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC FLOVENT ACTUATOR MCG 110; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number FP8P

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

Patient called to report a product issue with her inhaler.Patient stated she noticed around early (b)(6) that she was unable to remove the cap, it was too difficult for her to get off by herself and she required the help of her husband.Patient stated it would be a better design if the cap could be attached instead which would also help with the risk of it falling and becoming dirty.Patient stated she hopes this gets looked into asap.

Event Description

Additional information received from reporter on 2/23/2022 for report mw5107109.Reporter stated that one person having a problem with their device should be enough for the fda to make changes.

• Brand Name: FLOVENT ACTUATOR MCG 110
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC; 184 liberty corner rd; warren NJ 07059
• MDR Report Key: 13417886
• MDR Text Key: 284968360
• Report Number: MW5107109
• 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,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: FP8P
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female