MAUDE Adverse Event Report: SUNMED MDI SPACER; NEBULIZER

Model Number BR300

Device Problem Break (1069)

Patient Problem Airway Obstruction (1699)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer alleges that he was using item br300-the flap on the mouthpiece broke off and went into his airway.He needed the heimlich maneuver.

Event Description

The customer alleges that he was using item br300 the flap on the mouthpiece broke off and went into his airway.He needed the heimlich maneuver.

Manufacturer Narrative

After completion of investigation, it has been found that customer misuse was the main cause for this issue.Customer mouth/teeth positioning allowed for the safety valve to become detached and sequentially allowed for it to migrate into the holding chamber.The dhr was reviewed to ensure there could be no other contributing factors that would occur during production.No such contributors were uncovered.

• Brand Name: MDI SPACER
• Type of Device: NEBULIZER
• Manufacturer (Section D): SUNMED; 2710 northridge dr. suite a; grand rapids MI 49544
• MDR Report Key: 12295254
• MDR Text Key: 265774991
• Report Number: 1314417-2021-00011
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BR300
• Device Lot Number: 323666
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention