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

Model Number 1011-2447

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

Patient Problems Cellulitis (1768); Skin Inflammation/ Irritation (4545)

Event Date 05/16/2023

Event Type  Injury  

Event Description

39 year old female was implanted on (b)(6) 2023.They were seen at their 2 week wound healing check on (b)(6) 2023.The patient presented with an incision site that was hard to touch, pink and itchy.The physician assistant determined the site to not be infected.On (b)(6) 2023, the patient called the after hours hotline reported that the site was hot, swollen and red.The provider prescribed a 7-day antibiotic regimen (keflex).The patient was directed to contact their implanted physician.On (b)(6) 2023, the patient was seen by the physician assistant again and was instructed to finish the antibiotics.On (b)(6) 2023, the patient called to report continued signs of an infection.They were prescribed a second round of antibiotics (doxycycline) but had to stop treatment due to an allergic reaction.On (b)(6) 2023, the patient was seen by a company representative.The company representative was informed by medical staff that the patient may have an infected incision.Patient was put a third round of antibiotics (keflex).On (b)(6) 2023, the patient was seen by implanting physician who confirmed that the infection was cleared.Patient was activated on (b)(6) 2023.There were no related issues noted.Company medical advisors reviewed the photos provided by the implanting physician.They concluded it is likely the patient had a dermabond reaction which evolved into cellulitis of the incision area.The incision appears to be closed.

• 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 91355
• Manufacturer Contact: jacquelynn urso-bernick ; 28464 westinghouse place; valencia, CA 91355
• MDR Report Key: 17046441
• MDR Text Key: 316394899
• Report Number: 3010878085-2023-00003
• Device Sequence Number: 1
• Product Code: QPT
• UDI-Device Identifier: 00860007896903
• UDI-Public: (01)00860007896903(11)220609(17)230609
• 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: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: 1011-2447
• Device Catalogue Number: 1011-1422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 39 YR
• Patient Sex: Female