MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; CESAREAN SECTION TRAY

Model Number DYNJ04609I

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2021

Event Type  malfunction  

Event Description

Lap sponge package missing one lap sponge.Total of 9 in package not 10.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 13108350
• MDR Text Key: 282903066
• Report Number: 13108350
• Device Sequence Number: 1
• Product Code: OHM
• 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: 12/07/2021,11/30/2021

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: DYNJ04609I
• Device Catalogue Number: DYNJ04609I
• Device Lot Number: 21IBE1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2021
• Date Report to Manufacturer: 12/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9855 DA
• Patient Sex: Female