MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SPECIALTY ABSORPTIVE DRESSING; GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE

Model Number	15-011
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse noted a black spot was noted inside the dressing when opening - black spot was an intact fly.Dressing was taken away from patient area and a new sterile dressing package was opened and applied.No injury or impact to patient reported.
Additional Manufacturer Narrative
A user facility medwatch report ((b)(4)) was received 06 march 2023 reporting an intact fly on the sterile gauze.The sample was reported as available but has not yet been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted once additional information is available.
Additional Manufacturer Narrative
The sample of the dressing was returned to deroyal on (b)(6) 2023.Deroyal reviewed production and device history records and no other flies were found.An inventory inspection was also performed on three cases and no flies or additional discrepancies were found.Pest control information was also checked and was found to be being performed as required.A total of (b)(4)dressings have been sold between (b)(6), 2021 through (b)(6), 2023.This incident was the only issue of this nature reported in the same time frame.This yields a complaint to sales percentage of (b)(4).Root cause: it is possible that the insect was already in the raw material when it arrived at the production plant or that it fell into the raw material while it was spread in the process of cutting.However, an assembly error occurred as this fly should have been noticed in the folding of each dressing.The following corrective and preventative actions have taken place by deroyal: responsible assemblers were identified and notified of the non-conformance and quality control inspectors were informed and retrained to better inspect future work orders.This 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.
Additional Manufacturer Narrative
The sample of the dressing was returned to deroyal on march 3, 2023.Deroyal reviewed production and device history records and no other flies were found.An inventory inspection was also performed on three cases and no flies or additional discrepancies were found.Pest control information was also checked and was found to be being performed as required.A total of (b)(4) dressings have been sold between january 4, 2021 through april 5, 2023.This incident was the only issue of this nature reported in the same time frame.This yields a complaint to sales percentage of (b)(4).Root cause: it is possible that the insect was already in the raw material when it arrived at the production plant or that it fell into the raw material while it was spread in the process of cutting.However, an assembly error occurred as this fly should have been noticed in the folding of each dressing.The following corrective and preventative actions have taken place by deroyal: responsible assemblers were identified and notified of the non-conformance and quality control inspectors were informed and retrained to better inspect future work orders.This 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: SPECIALTY ABSORPTIVE DRESSING
• Common Device Name: GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer Contact: mary reeves ; 200 debusk lane; powell, TN 37849
• MDR Report Key: 19929622
• Report Number: 3010452421-2023-00002
• Device Sequence Number: 2760097
• Product Code: NAB
• UDI-Device Identifier: 00749756334662
• UDI-Public: 00749756334662
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2024

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 Model Number: 15-011
• Device Lot Number: 46808128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/07/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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