MAUDE Adverse Event Report: OSNOVATIVE SYSTEMS, INC. ENLUXTRA; DRESSING, WOUND, HYDROPHILIC

Model Number HCPCSA6196

Device Problem Material Discolored (1170)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Contact Dermatitis (4546)

Event Date 07/07/2022

Event Type  malfunction  

Event Description

New lot enluxtra absorbent dressing was "yellow" (usually white).It developed contact dermatitis rash.Pt had been using enluxtra dressings to right leg wound with excellent wound healing and no periwound skin breakdown or rashes.On approx (b)(6) 2022, the pt applied enluxtra from new shipment (new lot number).She noticed it was "yellow" rather than white when she opened the package, but it otherwise looked ok and no odor noted.Within "hours" of applying the product, she developed severe itching and removed the dressing.She had a bright red indurated rash in the exact shape of the dressing.

• Brand Name: ENLUXTRA
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): OSNOVATIVE SYSTEMS, INC.; 500 laurelwood rd; ste 1; santa clara CA 95054
• MDR Report Key: 15104831
• MDR Text Key: 296701955
• Report Number: MW5111117
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2022
• Device Model Number: HCPCSA6196
• Device Lot Number: 02281
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White