MAUDE Adverse Event Report: NEPHRON PHARMACEUTICALS / NEPHRON SC, INC. SODIUM CHLORIDE NEPHRON 7% 4ML ; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number 924231

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/24/2019

Event Type  Injury  

Event Description

Pt was hospitalized and is on antibiotics.

• Brand Name: SODIUM CHLORIDE NEPHRON 7% 4ML
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): NEPHRON PHARMACEUTICALS / NEPHRON SC, INC.
• MDR Report Key: 9535673
• MDR Text Key: 173337560
• Report Number: MW5091942
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00487900760
• UDI-Public: 00487900760
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 924231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 12 YR