MAUDE Adverse Event Report: AMSINO HEALTHCARE (USA), INC. 0.9% SODIUM CHLORIDE INHALATION; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number H583

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/20/2023

Event Type  Injury  

Event Description

Sodium chloride inhalation vial x 1 was given via nebulizer to child in the office.Mom reports that after the treatment once child was in the car developed multiple hives to face and body.The hives persisted over the next few days every time child was outside in the sun or if he was hot, mom reports the episodes are linked to the inhalation treatment with sodium chloride.All communication regarding the event was done on the phone or via email, mom refused to bring child in to clinic for evaluation in person.Refer to add'l documents in i2k.

• Brand Name: 0.9% SODIUM CHLORIDE INHALATION
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): AMSINO HEALTHCARE (USA), INC.
• MDR Report Key: 17855367
• MDR Text Key: 324809805
• Report Number: MW5146343
• 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: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: H583
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 13 KG
• Patient Ethnicity: Non Hispanic