MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; CCX - SUPPORT, PATIENT POSITION

Catalog Number M9504

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abrasion (1689); Skin Irritation (2076)

Event Date 12/23/2013

Event Type  Injury  

Event Description

The hospital reported that the head pillow causes facial abrasions and skin injuries.

Manufacturer Narrative

Describe event or problem: the hospital reported that the head pillow causes facial abrasions and skin injuries.Deroyal: the reported sample was not returned for evaluation.The bill of materials was reviewed and there were no changes in the manufacturing process or in the materials used to make the part.Furthermore, the product does not contain natural rubber latex.There have not been any previous reports of this nature for this finished good.This report was determined to be an isolated event with the root cause being undetermined.

• Brand Name: DEROYAL
• Type of Device: CCX - SUPPORT, PATIENT POSITION
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; maynardville TN
• Manufacturer Contact: courtney rinehart ; 200 debusk lane; powell, TN 37849
• MDR Report Key: 3608593
• MDR Text Key: 4171788
• Report Number: 1034876-2014-00001
• Device Sequence Number: 1
• Product Code: CCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M9504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/23/2013
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2013
• Date Manufacturer Received: 12/23/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other