MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DERMANET® AG 4 X 4, (10CM X 10CM); DRESSING, WOUND, DRUG

Model Number	46-DN44
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
"dermanet ag that was placed in the wound bed had granulation tissue that imbedded into its mesh design.Unable to separate it from the tissue without bleeding so the resident was sent to er.".
Additional Manufacturer Narrative
A user facility complaint was received on 11/17/2022 reporting "dermanet ag that was placed in the wound bed had granulation tissue that imbedded into its mesh design.Unable to separate it from the tissue without bleeding so the resident was sent to er." no additional information reported.Patient status is unknown at this time.The device was not returned to deroyal for testing.A review of the lot number given in the complaint was reviewed.The inventory check consisted of 7 dressings from the same lot, each of which were deemed acceptable to current specifications.The work orders and viscosity of algidex mixtures were reviewed for discrepancies that would cause the issue.No discrepancies were identified.The failure mode, effects, and criticality worksheet (fmea) was reviewed.No update was required.A trend analysis was also conducted, deroyal has sold (b)(4) of finished good 46-dn44 from november 2020 to present and during the review period found only this event was received for the product.This equated to a sales ratio of (b)(4).Root cause: due to no sample returned, no report of how long the patient wore the patch, and no report of if the patch was removed properly, the root cause is undetermined with no error found.There will be no corrective action taken due to the determination of the root cause.Deroyal will continue to monitor for trends around this product.The investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: DERMANET® AG 4 X 4, (10CM X 10CM)
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19928470
• Report Number: 2320762-2022-00013
• Device Sequence Number: 2846926
• Product Code: FRO
• UDI-Device Identifier: 00749756646611
• UDI-Public: 00749756646611
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2022

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
• Device Model Number: 46-DN44
• Device Lot Number: 57493643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 08/07/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown