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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. EPIMED RADIOPAQUE EPIDURAL CATHETER

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EPIMED INTERNATIONAL INC. EPIMED RADIOPAQUE EPIDURAL CATHETER Back to Search Results
Lot Number 11427899
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 09/07/2017
Event Type  Injury  
Event Description
Pt had catheter placed for loa procedure (b)(6) 2017. Pt left lsdc with catheter secured for infusion at watson clinic next day (b)(6) 2017. Catheter removed (b)(6) 2017 in office. Per md pt c/o back issues since removal. Fb identified. Dates of use: (b)(6) 2017 - (b)(6) 2017. Diagnosis or reason for use: low back and left leg pain. M. Devices group, (b)(6).
 
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Brand NameEPIMED RADIOPAQUE
Type of DeviceEPIDURAL CATHETER
Manufacturer (Section D)
EPIMED INTERNATIONAL INC.
MDR Report Key7544261
MDR Text Key109452417
Report NumberMW5077449
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2021
Device Lot Number11427899
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
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/24/2018 Patient Sequence Number: 1
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