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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EMED TECHNOLOGIES CORPORATION IV SCIG 36" 27G 9MM, SUB-410 SET, ADMINISTRATION, INTRAVASCULAR

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EMED TECHNOLOGIES CORPORATION IV SCIG 36" 27G 9MM, SUB-410 SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Difficult to Remove (1528)
Patient Problem Discomfort (2330)
Event Type  Injury  
Event Description
Pt reports having issues removing the needle after infusing. She is requesting different needles for the next infusion. There were no issues with the medication, only the discomfort when removing the needles. No other info known. Unk if md is aware. Reported to cvs/caremark by pt/caregiver.
 
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Brand NameIV SCIG 36" 27G 9MM, SUB-410
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
EMED TECHNOLOGIES CORPORATION
MDR Report Key8650907
MDR Text Key146496781
Report NumberMW5086967
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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