MAUDE Adverse Event Report: COVALON TECHNOLOGIES, LTD. DERMACOL/AG; COLLAGEN WOUND DRESSING WITH SILVER

Model Number	00503E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The complainant used the dressing along with other wound care supplies that were provided by mail from a medical supply company.The patient used the dressing in conjunction with medihoney and a zinc oxide paste wrap.He claimed to have used 3-4 dressings, and at a routine dressing change "2 days later" a worsening condition of the wound was noted.The patient has reported daily grievous pain and bodily injury with use of the product; however, no images or photos have been received yet by covalon after repeated attempts at contact and requests for additional information.

• Brand Name: DERMACOL/AG
• Common Device Name: COLLAGEN WOUND DRESSING WITH SILVER
• Manufacturer (Section D): COVALON TECHNOLOGIES, LTD.; 1660 tech ave.; unit 5; mississauga, ontario L4W 5 S7; CA L4W 5S7
• Manufacturer (Section G): COVALONTECHNOLOGIES, LTD; 1660 tech ave.; unit 5; mississauga, ontario L4W 5 S7; CA L4W 5S7
• Manufacturer Contact: kim crooks ; 1660 tech ave.; unit 5; mississauga, ontario L4W 5-S7 ; CA L4W 5S7
• MDR Report Key: 21411175
• Report Number: 3005004019-2025-00001
• Device Sequence Number: 9312010
• Product Code: FRO
• UDI-Device Identifier: 01714196503441
• UDI-Public: 01714196503441
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 00503E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDIHONEY; OTHER WOUND CARE SUPPLIES; ZINC OXIDE PASTE WRAP
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male