MAUDE Adverse Event Report: ROGERS FOAM CORPORATION ARM PROTECTOR, SURGICAL, ULNAR NERVE, 1.0 DENSITY; SUPPORT, PATIENT POSITION

Model Number	M9500E
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on 6/7/2023 reporting hair in bag.A supplier corrective action request (scar) was issued to the positioner supplier (b)(4).The sample has not been returned to deroyal for evaluation at this time.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once additional information becomes available.
Event or Problem Description
Hair in bag.
Additional Manufacturer Narrative
The sample nor picture of the sample were not returned to deroyal industries for evaluation.A supplier corrective action request (scar) was issued to the positioner supplier rogers foam corporation.Root cause: was unable to be determined by supplier rogers foam corporation as specific defective samples were not obtained.Potential root cause determined by rogers foam corporation: employees not wearing their hairnets correctly and the movement of the fans along with potential production line work process issue.The following corrective and preventive actions have taken place by rogers foam corporation: completed retraining with their employees, added fans to the maintenance plan, and will determine another means of transportation of the material from table to table.Deroyal reviewed failure modes and effects analysis (fmea) and corrective actions and preventative actions (capa) and no issues were found.Deroyal will continue to monitor for trends surrounding this item and issue.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: ARM PROTECTOR, SURGICAL, ULNAR NERVE, 1.0 DENSITY
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): ROGERS FOAM CORPORATION; 20 vernon street; sommerville MA 02145
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19944268
• Report Number: 1034876-2023-00002
• Device Sequence Number: 15311764
• Product Code: CCX
• UDI-Device Identifier: 00749756563321
• UDI-Public: 00749756563321
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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: M9500E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown