MAUDE Adverse Event Report: VALENCIA TECHNOLOGIES ECOIN PERIPHERAL NUEROSTIMULATOR; ECOIN UUI

Catalog Number 1011-1422

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/25/2024

Event Type  Injury  

Event Description

76 year old female implanted on (b)(6) 2023.On (b)(6) 2024, patient presented with an infection at the incision site.Patient was prescribed antibiotics.

• Brand Name: ECOIN PERIPHERAL NUEROSTIMULATOR
• Type of Device: ECOIN UUI
• Manufacturer (Section D): VALENCIA TECHNOLOGIES; 28464 westinghouse place; valencia CA 91355
• Manufacturer (Section G): VALENCIA TECHNOLOGIES; 28464 westinghouse place; valencia CA 91355
• Manufacturer Contact: jacquelynn urso-bernick ; 28464 westinghouse place; valencia 91355 ; 8333264687
• MDR Report Key: 18754371
• MDR Text Key: 335933235
• Report Number: 3010878085-2024-00003
• Device Sequence Number: 1
• Product Code: QPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2024
• Device Catalogue Number: 1011-1422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female