MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; ADHESIVE CLIP PACK

Model Number 74007-004

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Rash (2033); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)

Event Date 02/06/2022

Event Type  Injury  

Event Description

Patient's use of the available varieties of the adhesive clip over approximately two years resulted in skin irritation, rashes, erythema, and unspecified tissue injury.Patient indicated that wound surgeon consulting on the matter was concerned about continued use of the adhesive clips.Patient also reported that condition required intervention.No details about the nature of intervention provided were made available.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: ADHESIVE CLIP PACK
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; carlsbad CA 92008 2377
• Manufacturer (Section G): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 13971591
• MDR Text Key: 288356196
• Report Number: 3015425075-2022-00019
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74007-004
• Device Catalogue Number: 74007-004
• Device Lot Number: 56394-R3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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): Other