MAUDE Adverse Event Report: UNSURE; INHALER, METERED DOSE OR DRY POWDER

Device Problem Unsealed Device Packaging (1444)

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

Event Date 04/16/2020

Event Type  malfunction  

Event Description

Inhalers should be removed from original manufacturer container and have a tamper seal applied to the mouthpiece.Multiple inhalers did not have the tamper seal.Without this, it is unclear if an inhaler has been touched/opened/used or not and must be discarded due to the uncertainty.This creates unnecessary waste, particularly at a time when inhalers are on critical shortage.

• Type of Device: INHALER, METERED DOSE OR DRY POWDER
• Manufacturer (Section D): UNSURE
• MDR Report Key: 9981119
• MDR Text Key: 188354891
• Report Number: 9981119
• Device Sequence Number: 1
• Product Code: KCO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1