MAUDE Adverse Event Report: OK BIOTECH CO., LTD. PRODIGY MINI-MIST NEBULIZER; 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  malfunction  

Manufacturer Narrative

Because device was not returned to ok biotech, therefore, we were unable to perform further testing on the suspected device.Ok biotech reviewed the manufacturing record of this suspected device (meter serial number # (b)(4)), and the meter was qualified and released by the quality control department and shipped to (b)(6) on 12/15/2010.It had been 6 years.We are unable to confirm the complaint because device was not returned and no further information from customer has been received, this matter has to be closed out with undetermined root cause.

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: PORTABLE NEBULIZER
• Manufacturer (Section D): OK BIOTECH CO., LTD.; no. 91, sec. 2,; gongdao 5th road; hsinchu, 30070 ; TW 30070
• Manufacturer (Section G): OK BIOTECH CO., LTD.; no. 91, sec. 2,; gongdao 5th road; hsinchu, 30070 ; TW 30070
• Manufacturer Contact: joanna wang ; no. 91, sec. 2,; gongdao 5th road; hsinchu, 30070 ; TW 30070
• MDR Report Key: 6600315
• MDR Text Key: 76251701
• Report Number: 3005862821-2017-00042
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• 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
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• 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