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

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).

• Brand Name: EPIMED RADIOPAQUE
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC.
• MDR Report Key: 7544261
• MDR Text Key: 109452417
• Report Number: MW5077449
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Lot Number: 11427899
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 76