MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. EQUIPMENT COVER; COVER, BARRIER, PROTECTIVE

Catalog Number 396009

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/04/2019

Event Type  malfunction  

Event Description

Tear/hole present upon opening equipment cover.Fda safety report id # (b)(4).

• Brand Name: EQUIPMENT COVER
• Type of Device: COVER, BARRIER, PROTECTIVE
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; athens TX 75751
• MDR Report Key: 8692360
• MDR Text Key: 148004825
• Report Number: MW5087284
• Device Sequence Number: 1
• Product Code: MMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2024
• Device Catalogue Number: 396009
• Device Lot Number: 11256726
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR