MAUDE Adverse Event Report:; RADIATION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dehydration (1807); Inflammation (1932); No Code Available (3191)

Event Date 01/12/2015

Event Type  Injury  

Event Description

Mc1273 cycle: 1.Mucositis oral grade 3, attribution: 3.Dehydration: grade 3, attribution: 3.Patient presented to local emergency room with acute mucositis, poor oral intake and dehydration (secondary) to mucositis) he was admitted to the hospital for iv fluids and antibiotics.Chest exam was done and was negative.Therapy dates: (b)(6) 2014 - (b)(6) 2015.Diagnosis for use: ca left tonsil.

• Type of Device: RADIATION
• MDR Report Key: 4450792
• MDR Text Key: 5387195
• Report Number: MW5040359
• 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: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: DOCETAXEL 31 MG DI & D8 IV; DOCETAXEL 31 MG DI & D8 IV
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 80