MAUDE Adverse Event Report: DEROYAL INDUSTRIES DEROYAL ESMARK BANDAGES; ESMARK, BANDAGE 4X9FT

Catalog Number	30-196
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
White flaking particles coming off esmark packaging which is placed inside bowl within custom procedure kit 880119-hand pack, lot #1925636745, udi#(b)(4).The user reported that this occured on 3 different dates: (b)(6) 2020.The user reported that the bowl was wiped out by the scrub nurse before pouring irrigation into bowl.There was no reported harm to the patient nor was there a delay to the case.

• Brand Name: DEROYAL ESMARK BANDAGES
• Common Device Name: ESMARK, BANDAGE 4X9FT
• Manufacturer (Section D): DEROYAL INDUSTRIES; powell, tn
• MDR Report Key: 9844833
• Report Number: 3014527682-2020-00004
• Device Sequence Number: 16848417
• Product Code: FQM
• UDI-Device Identifier: 50749756024537
• UDI-Public: 50749756024537
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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 Catalogue Number: 30-196
• Device Lot Number: 50118138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1