MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEFOGGER; ANTI-FOG SOLUTION

Model Number	28-0101B
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (b)(4) was received indicating that the x-ray element separated from the anti-fog foam pad (finished good 28-0101b) during a procedure.The x-ray detectable strip fell into the patient but was located after detaching.There was no patient injury.A sample was unavailable to return for evaluation.The complaint investigator reviewed the work order for the reported lot number (48028715).There were 27 defects from this lot; however, these parts were rejected due to issues with the paper backing, which is unrelated to the reported event.No discrepancies were identified in the work order that could have contributed to the reported failure.No change has been made to the raw materials or the converting process for the anti-fog pad.The investigation is ongoing at this time.When new and critical information is available, this report will be updated.
Event or Problem Description
The x-ray detectable strip came off the anti-fog pad during a procedure.
Additional Manufacturer Narrative
Root cause: the photo of the defective sample confirmed the reported defect.However, the sample itself was unavailable for evaluation.A root cause for the reported issue was unable to be determined.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint (call 46079) was received indicating that the x-ray element separated from the anti-fog foam pad (finished good 28-0101b) during a procedure.The x-ray detectable strip fell into the patient but was located after detaching.There was no patient injury.A sample was unavailable to return for evaluation.A photo of the defective product was received, but it did not aid in the investigation of the reported issue.The complaint investigator reviewed the work order for the reported lot number (48028715).There were 27 defects from this lot; however, these parts were rejected due to issues with the paper backing, which is unrelated to the reported event.No discrepancies were identified in the work order that could have contributed to the reported failure.No change has been made to the raw materials or the converting process for the anti-fog pad.The investigation is complete at this time.If new and critical information is available, this report will be updated.
Event or Problem Description
The x-ray detectable strip came off the anti-fog pad during a procedure.

• Brand Name: DEFOGGER
• Common Device Name: ANTI-FOG SOLUTION
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• MDR Report Key: 8317853
• Report Number: 1060680-2019-00001
• Device Sequence Number: 1650008
• Product Code: OCT
• UDI-Device Identifier: 00749756301749
• UDI-Public: 00749756301749
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K982465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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
• Operator of Device: Health Professional
• Device Model Number: 28-0101B
• Device Lot Number: 48028715
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1