MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES, INC; SPONGE

Lot Number PL1408E01

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

The sponges are used for breast reduction surgery.The sponges are "falling apart" during surgery and require "copious amounts" of irrigation as well as careful examination of the surgical field ongoing to assure no strands are left behind in the wound which could contribute to an infection.This is the second time this has occurred with this brand of sponge, per rn staff.

• Type of Device: SPONGE
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES, INC; 25 heywood rd.; arden NC 28704
• MDR Report Key: 4373354
• MDR Text Key: 5236882
• Report Number: 4373354
• Device Sequence Number: 1
• Product Code: LWH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• 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?: Yes
• Device Operator: Nurse
• Device Lot Number: PL1408E01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2014
• Patient Sequence Number: 1