MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ORTHOPLASTICS TOTES; PLASTIC SURGERY AND ACCESSORIES KIT

Model Number CMPJ13284A

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2023

Event Type  malfunction  

Event Description

The medline orthoplastics tote are continuing to miss light handle covers, surgical drapes, label sheet for labeling, and still a plethora of unnecessary supplies in the tote that was already discussed which is still not up to par.

• Brand Name: ORTHOPLASTICS TOTES
• Type of Device: PLASTIC SURGERY AND ACCESSORIES KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 18181183
• MDR Text Key: 328638660
• Report Number: 18181183
• Device Sequence Number: 1
• Product Code: FTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/15/2023

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
• Device Model Number: CMPJ13284A
• Device Lot Number: 23HBC322
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1