MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE; COUNTER, SPONGE, SURGICAL

Model Number SPCT1002

Patient Problem Insufficient Information (4580)

Event Date 02/09/2023

Event Type  malfunction  

Event Description

One row of pockets did not have a seam, so the medichoice sponges were falling through to the next row of pockets.

• Brand Name: MEDICHOICE
• Type of Device: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 11900 north lakeridge pkwy; ashland VA 23005
• MDR Report Key: 18245965
• MDR Text Key: 329479597
• Report Number: 18245965
• Device Sequence Number: 1
• Product Code: LWH
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SPCT1002
• Device Lot Number: 2208LY09A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1