MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES INC. MEDICAL ACTION INDUSTRIES INC. SPONGE: LAP 18X18 W XR; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 402

Device Problem Material Disintegration (1177)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2021

Event Type  malfunction  

Event Description

Excessive lint coming from the lap sponges and the hospital laundered sterile blue towels, creating possible contamination.One surgeon has complained of this occurring.No other issues voiced from this surgeon since the initial complaint.No other surgeons have voiced concerns.

• Brand Name: MEDICAL ACTION INDUSTRIES INC. SPONGE: LAP 18X18 W XR
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES INC.; 25 heywood road; arden NC 28704
• MDR Report Key: 11574094
• MDR Text Key: 242436182
• Report Number: 11574094
• Device Sequence Number: 1
• Product Code: GDY
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 402
• Device Lot Number: 1904JK304A
• 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: 03/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA