MAUDE Adverse Event Report: OK BIOTECH COMPANY LTD PRODIGY MINI-MIST PORTABLE NEBULIZER

Model Number 32500A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Asthma (1726)

Event Date 10/09/2016

Event Type  Injury  

Event Description

End user reported that his prodigy nebulizer was not misting properly and medical attention was sought in (b)(6) 2016 after he suffered an asthma attack.He visited the emergency room and received one albuterol treatment.No further details were provided.

• Brand Name: PRODIGY MINI-MIST PORTABLE NEBULIZER
• Type of Device: MINI-MIST PORTABLE NEBULIZER
• Manufacturer (Section D): OK BIOTECH COMPANY LTD; no. 91, sec 2; gongdao 5th rd; hsinchu, taiwan 300 ; TW 300
• MDR Report Key: 6056735
• MDR Text Key: 58401094
• Report Number: 3008789114-2016-00095
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2016,10/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 32500A
• Device Catalogue Number: 32500A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2016
• Distributor Facility Aware Date: 10/09/2016
• Event Location: Home
• Date Report to Manufacturer: 10/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LISINOPRIL; MELOXICAM; METFORMIN; SINGULAIR
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 115