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MAUDE Adverse Event Report: RADIATION
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RADIATION
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Device Problem
Insufficient Information (3190)
Patient Problem
Dysphagia/ Odynophagia (1815)
Event Date
06/23/2014
Event Type
Injury
Event Description
Peg tube placement for grade 3 oral pain attributed to 2 (n-acetylcysteine).Grade 3 dysphagia attributed to 2 (n-acetylcysteine).Diagnosis for use: oral cancer, oral pain.Radiation dose: 6000 cgy.Therapy dates: (b)(6) 2014.
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Brand Name
RADIATION
Type of Device
RADIATION
MDR Report Key
4253511
MDR Text Key
18289932
Report Number
MW5039038
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
11/04/2014
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
11/06/2014
Patient Sequence Number
1
Treatment
N-ACETYLCYSTEINE 5 ML (B)(6) 2014
Patient Outcome(s)
Other;
Patient Age
56 YR
Patient Weight
80
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