MAUDE Adverse Event Report: CHEMISTRY AND RADIATION ; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/13/1993

Event Type  Injury  

Event Description

Twenty-seven years ago, i had nasal cancer.I had radiation to my jaw on the side of my face.Now my jaw is locked and i can only open it a half of inch; (b)(6) hospital.Fda safety report id# (b)(4).

• Brand Name: CHEMISTRY AND RADIATION
• Type of Device: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• MDR Report Key: 9519745
• MDR Text Key: 172841738
• Report Number: MW5091886
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/1994
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 102