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 12/19/2023

Event Type  Injury  

Event Description

75 year old female with edema implanted on (b)(6) 2023.On 12/19/2023, patient reported an issue with the incision.Patient was diagnosed with an infection and prescribed an antibiotic.Additionally, patient received treatment from a wound care clinic where the wound was debrided.Patient is healing well.

• 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, CA 91355 ; 8333264687
• MDR Report Key: 18804402
• MDR Text Key: 336508070
• Report Number: 3010878085-2024-00006
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Catalogue Number: 1011-1422
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 74 YR
• Patient Sex: Female