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

Model Number 32500A

Device Problem Device Operational Issue (2914)

Patient Problems Asthma (1726); Itching Sensation (1943); Sweating (2444)

Event Date 04/04/2017

Event Type  Injury  

Event Description

End user reported that her prodigy nebulizer mini-mist was not functioning properly and medical attention was sought (b)(6) 2016 between 3:00 to 4:00 pm.End user stated she was not able to breath and felt tightness in her chest, was itchy around her neck, sweating and experienced dizziness.The end user was taken to the er and admitted to the hospital for 4 days.She received breathing treatments and was able to breath easier.Upon discharge she was instructed to rest and continue with her breathing treatments.The end user also received prednisone to assist with her asthma and breathing issues.No further details were provided in relations to this medical event.

• Brand Name: PRODIGY MINI-MIST NEBULIZER
• Type of Device: MINI-MIST PORTABLE NEBULIZER
• Manufacturer (Section D): OK BIOTECH COMPANY LTD; no. 91, sec 2; gongdao 5th rd; hsinchu, 300 ; TW 300
• MDR Report Key: 6533705
• MDR Text Key: 74053085
• Report Number: 3008789114-2017-00031
• 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: 05/01/2017,04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 05/01/2017
• Distributor Facility Aware Date: 04/04/2017
• Event Location: Home
• Date Report to Manufacturer: 05/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALBUTEROL; ASTHMA (NAC); GENERIC FLEXERIL (MUSCLE RELAXER); IBUPROFEN 800 MG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 104