MAUDE Adverse Event Report: FRESENIUS KABI MIDAZOLAM 2MG/2ML; INTRODUCER, SYRINGE NEEDLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/22/2021

Event Type  Injury  

Event Description

Patient has a latex allergy and had a severe allergic reaction most likely as a result of fresenius simplist syringes of midazolam 2mg/2ml, ondansetron 4mg/2ml, and dexamethasone 4mg/1ml."after calling the".

• Brand Name: MIDAZOLAM 2MG/2ML
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): FRESENIUS KABI; three corporate dr.; lake zurich IL 60047
• MDR Report Key: 13472134
• MDR Text Key: 285252230
• Report Number: MW5107227
• Device Sequence Number: 3
• Product Code: KZH
• 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: 04/22/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White