MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. HYPERSAL; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number 7M003

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

Patient Problem Death (1802)

Event Date 08/27/2019

Event Type  Death  

Event Description

Unspecified acquaintance ((b)(6)) reported death of pt.Fda safety report id# (b)(4).

• Brand Name: HYPERSAL
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 9128668
• MDR Text Key: 160372922
• Report Number: MW5090064
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 83490020760
• UDI-Public: 83490-0207-60
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Lot Number: 7M003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ACTONEL ; ADVAIR ; ALBULTEROL ; AZITHROMYCIN ; BENZONATATE ; BUMETANIDE; CEFUROXIME; FLUCONAZOLE; HYDROMORPHONE; ITRACONAZOLE; LEVEMIR ; METALOZONE ; NOVOLOG; ONDANSETRON ; PREDNISONE
• Patient Outcome(s): Death
• Patient Age: 77 YR