MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC.. CCASC LAPAROTOMY PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10558
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hair found imbedded in the lap pad.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was recieved on 11/2/2022 reporting a hair found imbedded in the lap pad.A supplier corrective action request (scar) was sent to the supplier (b)(4).The sample was returned to deroyal for evaluation on 11/7/2022.This investigation is ongoing 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 was returned to deroyal for evaluation on 11/07/2022.A supplier corrective action request (scar) was issued to the sponge lap supplier g d medical.Root cause: it was determined that certain workers involved in the manufacturing process was not properly following the gowning procedure in the folding workshop which led to the hair found embedded.The following corrective and preventive actions have taken place by g d medical: the employees involved in the manufacturing were re-trained on gowning procedures to avoid any hair left on the products.We will continue to monitor and track any reoccurrence of such issue.Production records were reviewed and no issues were found.An inventory check of the sponge laps was made by deroyal and a total of 125 of the 5-1918 sponge laps were inspected with no discrepancies identified.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 was returned to deroyal for evaluation on 11/07/2022.A supplier corrective action request (scar) was issued to the sponge lap supplier g d medical.Root cause: it was determined that certain workers involved in the manufacturing process was not properly following the gowning procedure in the folding workshop which led to the hair found embedded.The following corrective and preventive actions have taken place by g d medical: the employees involved in the manufacturing were re-trained on gowning procedures to avoid any hair left on the products.We will continue to monitor and track any reoccurrence of such issue.Production records were reviewed and no issues were found.An inventory check of the sponge laps was made by deroyal and a total of 125 of the 5-1918 sponge laps were inspected with no discrepancies identified.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: CCASC LAPAROTOMY PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC..; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC..; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19928467
• Report Number: 3005011024-2022-00034
• Device Sequence Number: 2846923
• Product Code: LRO
• UDI-Device Identifier: 00749756364430
• UDI-Public: 00749756364430
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• 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 Health Care Professional
• 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: 89-10558
• Device Lot Number: 57392551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• 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
• 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