MAUDE Adverse Event Report: RESPIRATORY DELIVERY SYSTEMS, INC MICROSPACER; MOUTHPIECE, BREATHING

Model Number 47360-0172-01

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 05/09/2023

Event Type  malfunction  

Event Description

Patient was prescribed a microspacer for use with an inhaler.The microspacer split and became unusable after 3 uses with the inhaler.

• Brand Name: MICROSPACER
• Type of Device: MOUTHPIECE, BREATHING
• Manufacturer (Section D): RESPIRATORY DELIVERY SYSTEMS, INC
• MDR Report Key: 16919707
• MDR Text Key: 315265550
• Report Number: MW5117490
• Device Sequence Number: 1
• Product Code: BYP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 47360-0172-01
• Device Lot Number: 0007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White