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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Swelling (2091)

Event Type  Injury  

Event Description

Water blister development on the hips post radiation.Diagnosis or reason for use: breast cancer.

• Brand Name: RADIATION THERAPY
• Type of Device: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• MDR Report Key: 7762503
• MDR Text Key: 116639779
• Report Number: MW5078937
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 86