MAUDE Adverse Event Report: IVAX PHARMACEUTICAL / TEVA PHARMACEUTICAL PROAIR HFA; INHALER, NASAL

Device Problem Contamination (1120)

Patient Problems Fever (1858); Pain (1994); Reaction (2414); Lethargy (2560)

Event Type  Injury  

Event Description

Reporter stated that nine months ago, his dr prescribed inhaler for his asthma attack.However, the medication he received was different from what his dr prescribed.He was having pain, fever, became lethargic, getting slower and slower.He said he could not figure out why he was feeling this way.He stopped the medication 2 days ago, and his pain subsiding.He believed that the medication is contaminated for him to have these kind of allergic reaction.He also thinks they are selling the medication at a discount rate because it is contaminated.

• Brand Name: PROAIR HFA
• Type of Device: INHALER, NASAL
• Manufacturer (Section D): IVAX PHARMACEUTICAL / TEVA PHARMACEUTICAL
• MDR Report Key: 7837150
• MDR Text Key: 119039385
• Report Number: MW5079516
• Device Sequence Number: 1
• Product Code: KCO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/01/2019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 100