MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. STERILE TABLE COVER FROM SHOULDER ARTHROSCOPY PACK; ORTHOPEDIC TRAY

Catalog Number CMPJ08211A

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2021

Event Type  malfunction  

Event Description

Cut in sterile table cover.Fda safety report id# (b)(4).

• Brand Name: STERILE TABLE COVER FROM SHOULDER ARTHROSCOPY PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 11789897
• MDR Text Key: 249685660
• Report Number: MW5101219
• Device Sequence Number: 1
• Product Code: OJH
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: CMPJ08211A
• Device Lot Number: 20HB0550
• 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