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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT
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EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 09/20/2019
Event Type  Injury  
Event Description
Back pain at the site of epidural placement after labor. Currently five months postpartum. Fda safety report id# (b)(4).
 
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Brand NameEPIDURAL CATHETER
Type of DeviceANESTHESIA CONDUCTION KIT
MDR Report Key9754208
MDR Text Key181521926
Report NumberMW5093304
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 02/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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?
Type of Device Usage

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