MAUDE Adverse Event Report: RADIATION

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Vaso-Vagal Response (2661)

Event Date 11/03/2014

Event Type  Injury  

Event Description

Acute hypotension grade 4 attribution 3.Vasovagal reaction grade 4 attribution 3.Cycle 1.Pt was started on docetaxel, after 2 mins of chemo infusion, pt started having an acute reaction.He was hypotensive (80s/50s) and was passing out.Chemo infusion was discontinued.He was resuscitated with iv fluids at 750 ml/hour and pt was able to slowly recover with waking up and was responsive.An ekg was done and was unremarkable.His vital signs were back to stable range (130s/80s) in around 15 to 20 mins and he was able to go home.Diagnosis for use: right tonsil carcinoma.Dose, frequency, and route used/therapy dates: radiation, bid for 14 days.

• Brand Name: RADIATION
• Type of Device: RADIATION
• MDR Report Key: 4270293
• MDR Text Key: 5293812
• Report Number: MW5039149
• Device Sequence Number: 1
• Product Code: IYE
• 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: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2014
• Patient Sequence Number: 1
• Treatment: DOCETAXEL, 28 MG, DAYS 1 & 8, IV
• Patient Outcome(s): Required Intervention
• Patient Weight: 73