MAUDE Adverse Event Report: SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD NU-GEL¿ HYDROGEL WITH ALGINATE; NAD

Model Number NU-GEL

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Reaction (2414)

Event Date 08/24/2019

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged pain, reaction, and potential infection are related to the nu-gel¿ hydrogel.Kci/systagenix determined the planned surgery and previous graft loss were deemed not related to nu-gel¿ hydrogel.Device labeling, available in print states: indications: nu-gel¿ hydrogel is a transparent hydro active amorphous gel containing sodium alginate.The hydrogel creates a moist wound healing environment which assists with natural autolytic debridement whilst the alginate component enhances its absorptive capabilities.The gel can be used to soften and hydrate eschar by facilitating rehydration of the wound.Nu-gel¿ hydrogel is indicated for debridement and desloughing of wounds together with the management of chronic wounds throughout all stages of the healing process.[deviation for spanish: nu-gel¿ hydrogel is indicated for the treatment of decubitus ulcers and varicose in all states of healing.Precautions: if wound infection develops, appropriate antimicrobial therapy should be initiated.The use of nu-gel¿ hydrogel may be continued under medical supervision.Nu-gel¿ hydrogel contains propylene glycol which might cause irritation or sensitisation in a small number of patients; if such reactions are noted, use of nu-gel¿ hydrogel should be discontinued.

Event Description

On (b)(6) 2019, the following information was reported to kci/systagenix by the patient's daughter: the patient was post operatively using the nu-gel¿ hydrogel with alginate for a few days and allegedly experienced significant pain after product use.On (b)(6) 2019, the following information was reported to kci/systagenix by the patient's daughter: on (b)(6) 2019, the patient allegedly experienced a reaction.The patient reportedly has no known allergies to the nu-gel¿ hydrogel ingredients.The physician advised the patient to stop the treatment, and allegedly believes there is an infection present.The physician has started the patient on an antibiotic regimen.10 plus bottles of the nu-gel¿ hydrogel were allegedly associated with this adverse reaction.The reaction and potential infection have been reviewed and are proceeding with planned surgery.On (b)(6) 2019, the following information was reported to kci/systagenix by the physician: the reported planned surgery was not related to nu-gel¿ hydrogel.The patient experienced a previous 20% graft loss which was replaced on (b)(6) 2019.The new graft is reportedly healing well as of (b)(6) 2019.No additional information is available.Kci/systagenix has made multiple unsuccessful attempts to obtain the device identifier, and the product was not returned.Therefore, a device evaluation and device history review could not be performed.

• Brand Name: NU-GEL¿ HYDROGEL WITH ALGINATE
• Type of Device: NAD
• Manufacturer (Section D): SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD; gargrave; north yorkshire, BD23 3RX; UK BD23 3RX
• Manufacturer Contact: steve jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 9147893
• MDR Text Key: 167415344
• Report Number: 3007663067-2019-00004
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NU-GEL
• Device Catalogue Number: MNG415
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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