Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERX HEALTHCARE CORP. AMERIGEL HYDROGEL WOUND DRESSING "ADVANCED FORMULA"; DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AMERX HEALTHCARE CORP. AMERIGEL HYDROGEL WOUND DRESSING "ADVANCED FORMULA"; DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC Back to Search Results
Lot Number 760
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Swelling (2091); Impaired Healing (2378); Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 01/14/2019
Event Type  Injury  
Event Description
After re-section of left large toenail, applied wound dressing and several days later, it began swelling and oozing.Skin appeared to be like necrosis.Wound had rancid smell.Stopped using gel.It does not appear to be healing despite amoxicillin antibiotics.Signs of skin infection like oozing, heat, swelling, redness, or pain.Nail resection of left large toenail.Did the problem stop after the person reduced the dose or stopped taking or using the product? no.How was it taken or used: 1 ounce(s), twice a day, topical.Date the person started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2019.Reason for use: wound treatment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AMERIGEL HYDROGEL WOUND DRESSING "ADVANCED FORMULA"
Type of Device
DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
Manufacturer (Section D)
AMERX HEALTHCARE CORP.
MDR Report Key8274016
MDR Text Key134179037
Report NumberMW5083323
Device Sequence Number1
Product Code MGQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date10/31/2020
Device Lot Number760
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
Patient Weight97
-
-