MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. CONTAINER DENTURE AQUA W/LID NOVAPLUS; GENERAL SURGERY TRAY

Model Number NOVA30393

Device Problems Fitting Problem (2183); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2020

Event Type  malfunction  

Event Description

Many of the lids do not fit properly onto the cups, allowing for water to spill out or lid to not be fastened at all.Also, when cups are stacked, it is extremely difficult to pull them apart.

• Brand Name: CONTAINER DENTURE AQUA W/LID NOVAPLUS
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 10785366
• MDR Text Key: 214577762
• Report Number: 10785366
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020

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
• Device Operator: No Information
• Device Model Number: NOVA30393
• Device Lot Number: 075111
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1