MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. NEURO SPONGE 1/2 X 2 20/CS; GAUZE/SPONGE, INTERNAL

Model Number	30-068
Medical Device Problem Codes	Material Fragmentation (1261); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The product is leaving bits of "lint" or pieces of cotton were coming off the cottonoids.It appeared as if there were white pieces of hair in the wound.
Additional Manufacturer Narrative
A complaint was received on 6/03/2024 reporting "the product is leaving bits of "lint" or pieces of cotton were coming off the cottonoids.It appeared as if there were white pieces of hair in the wound.The complaint states that a sample will be provided.A supplier corrective action request (scar) has been issued to the supplier.This investigation is ongoing at this time.No further information is available at this time.We will provide a follow-up report if additional information becomes available.
Additional Manufacturer Narrative
A complaint was received on 6/03/2024 reporting "the product is leaving bits of "lint" or pieces of cotton were coming off the cottonoids.It appeared as if there were white pieces of hair in the wound." the complaint states that a sample was not available.A deroyal quality representative completed a review of inventory on hand lot number 60858981, there were no issues found.A supplier corrective action request (scar) was issued to the supplier (b)(4) on 6/17/2024.The scar was returned 7/17/2024 stating that the exact "root cause could not be determined".They identified a potential cause connected to end user handling, stating that excessive handling or sharp instruments came into contact with the non-woven material during use.The supplier completed material inspections, in-process & finished good evaluations and confirmed that material integrity was maintained.They stated that neuro neutec sponge is manufactured from a non-woven textile fabric, any sharp tools or cutting devices can damage the sponge, any small protruding parts could snag the sponge and excessive handling may cause fibers from non-woven sponge material." this investigation is complete at this time.No further information is available at this time.We will provide a follow-up report if additional information becomes available.

• Brand Name: NEURO SPONGE 1/2 X 2 20/CS
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: rose earl ; 200 debusk lane; powell, TN 37849 ; 8653621051
• MDR Report Key: 19656517
• Report Number: 1060680-2024-00003
• Device Sequence Number: 6483918
• Product Code: EFQ
• UDI-Device Identifier: 00749756037877
• UDI-Public: 00749756037877
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K791871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: Other
• Device Model Number: 30-068
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/13/2024
• 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
• Patient Sex: Unknown