MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE LAP SPONGES; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number MDS252512LF

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 08/20/2021

Event Type  malfunction  

Event Description

Medline basic ortho tray pack lap sponges contained an extra sponge (6 vs 5) which if not caught can alter correct sponge counts.Medline lap sponges mds252512lf, lot: 84321040049.Fda safety report id# (b)(4).

• Brand Name: MEDLINE LAP SPONGES
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 12365750
• MDR Text Key: 268305901
• Report Number: MW5103487
• Device Sequence Number: 2
• Product Code: GDY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MDS252512LF
• Device Lot Number: 84321040049
• 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
• Patient Age: 68 YR