MAUDE Adverse Event Report: RST SANEXAS NEOGEN SERIES

Lot Number 1712

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

Patient Problems Erythema (1840); Discomfort (2330); Superficial (First Degree) Burn (2685); Blister (4537)

Event Date 06/27/2021

Event Type  Injury  

Manufacturer Narrative

This device was a used system purchased from an outside source.Diagnostics and testing were offered to verify device functioning appropriately.Client wanted to replace all accessories without testing in april of 2021.Invoice was "too expensive" and the accessories were cancelled and a reminder to test those accessories prior to use was given.On august 5th client called to replace "defective" accessory.On 8/6/2021 it was discovered the replacement was due to an injury.It was established testing was not properly done and the electrode was not in good condition.The device functions as intended and there are no reports of issues outside the accessory.

Event Description

Patient developed burn wound on left wrist post treatment on (b)(6) 2021.Patient expressed feeling discomfort during treatment and intensity levels were adjusted.Patient was referred to wound care center.Patient presented with redness and blistering.Experienced discomfort in left wrist for a couple weeks, needed drainage, dressings and antibiotics.Reported as doing better - (b)(6) 2021.

• Brand Name: NEOGEN SERIES
• Type of Device: NEOGEN
• Manufacturer (Section D): RST SANEXAS; 313 pilot rd.; ste. a; las vegas NV 89119
• Manufacturer (Section G): RST-SANEXAS; 313 e pilot rd.; ste. a; las vegas NV 89119
• Manufacturer Contact: morhea sorgnard ; 313 pilot rd; ste. a; las vegas, NV 89119 ; 7023152999
• MDR Report Key: 12575757
• MDR Text Key: 274918470
• Report Number: 2954348-2021-00001
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 1712
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 132