MAUDE Adverse Event Report: CASSEMCO INC. HEAD POSITIONER,SURGICAL, 24/C, SOFT TOUCH HEAD PILLOW; SUPPORT, PATIENT POSITION

Model Number	M9504
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abrasion (1689); Skin Tears (2516)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A user facility reported on 4/21/2023, that there was some abrasion and skin tearing on patients face after use of a surgical head positioner.The head positioner is not available for return.A supplier corrective action request (scar) will be sent to cassemco inc.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information is concluded from the investigation.
Event or Problem Description
Some abrasion and skin tearing on patients face.
Additional Manufacturer Narrative
A supplier corrective action request (scar) was issued to the foam supplier cassemco.Root cause: was determined to be unknown by the supplier as found all inventory was within conformance standards.Corrective and preventative actions: cassemco did not take any corrective or preventative actions as no problem was found.Because no lot number was given, deroyal industries reviewed the last three lots sent to complaint reporting customer, and no issues were found.Deroyal also reviewed inventory and found it to be acceptable.No engineering changes or corrective action or preventative actions were found to be related to this issue.A complaint to sales ratio was calculated between april 2021 to may 2023 sold (b)(4) units of the finished good ((b)(4) eaches) and during that same period received one complaint.This creates a ratio of (b)(4).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: HEAD POSITIONER,SURGICAL, 24/C, SOFT TOUCH HEAD PILLOW
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): CASSEMCO INC.; 728 e. 15th street; cookeville TN 38503
• 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: 19931681
• Report Number: 1034876-2023-00001
• Device Sequence Number: 11447163
• Product Code: CCX
• UDI-Device Identifier: 00749756599658
• UDI-Public: 00749756599658
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/14/2023

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: M9504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown