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MAUDE Adverse Event Report: SOLESTA 50MG/ML
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SOLESTA 50MG/ML
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Device Problem
Device Operates Differently Than Expected (2913)
Patient Problem
Complaint, Ill-Defined (2331)
Event Date
07/01/2014
Event Type
Injury
Event Description
Pt states his solesta tx was ineffective.Dates of use: (b)(6) 2014.Dose or amount: 4 pfs one time.
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Brand Name
SOLESTA 50MG/ML
Type of Device
SOLESTA 50MG/ML
MDR Report Key
3999586
MDR Text Key
4779606
Report Number
MW5037661
Device Sequence Number
1
Product Code
LNM
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Pharmacist
Type of Report
Initial
Report Date
08/05/2014
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
08/05/2014
Patient Sequence Number
1
Patient Age
38 YR
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