MAUDE Adverse Event Report: DR. REDDYS EMEND FOSAPREPITANT; CONTAINER, LIQUID MEDICATION, GRADUATED

Lot Number CSA06001A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Reaction to Medicinal Component of Device (4574); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/10/2021

Event Type  Injury  

Event Description

Patient in chemo today for cycle 1 day 1 of oxaliplatin.She developed flushing and sob within 2-3 minutes of the emend being started.Emend was stopped and over the next 5-8 minutes all of her symptoms resolved.When the reaction started bp and hr was elevated.Several minutes after the emend was stopped bp was 117/62 and hr 57 with oxygen sat 110% on ra.Fda safety report id # (b)(4).

• Brand Name: EMEND FOSAPREPITANT
• Type of Device: CONTAINER, LIQUID MEDICATION, GRADUATED
• Manufacturer (Section D): DR. REDDYS; 107 college rd e; princeton NJ 08540
• MDR Report Key: 11817301
• MDR Text Key: 250680466
• Report Number: MW5101320
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: CSA06001A
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 64