MAUDE Adverse Event Report: MEDLINE INDUSTRIES LAP SPONGES; SPONGES, GAUZE

Catalog Number MDS241518

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2014

Event Type  No Answer Provided  

Event Description

A pack of lap pads was added to the or field and counted.The package contained only 4 lap pads.They were removed from the field.The packaging was bagged and labeled for the nurse manager.

• Brand Name: LAP SPONGES
• Type of Device: SPONGES, GAUZE
• Manufacturer (Section D): MEDLINE INDUSTRIES; 1 medline place; mundelein IL 60060
• MDR Report Key: 4432476
• MDR Text Key: 5376947
• Report Number: 4432476
• Device Sequence Number: 1
• Product Code: GDY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Catalogue Number: MDS241518
• Device Lot Number: 140608
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2015
• Patient Sequence Number: 1