MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL ELASTIC BANDAGE; BANDAGE, ELASTIC

Catalog Number 31-486

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2019

Event Type  malfunction  

Event Description

Deroyal elastic bandages with debris in sterile package.Fda safety report id# (b)(4).

• Brand Name: DEROYAL ELASTIC BANDAGE
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.
• MDR Report Key: 8518982
• MDR Text Key: 142237532
• Report Number: MW5085900
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: 31-486
• Device Lot Number: 48904201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1