MAUDE Adverse Event Report: MEDICAL ACTION, INDUSTRIES, INC. 18 INCH BY 18 INCH LAP SPONGES

Lot Number	1601JK304A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
During the count of lap sponges, a noise was heard and upon investigation, it was found the ring from one of the lap sponges had fallen on the floor.

• Brand Name: 18 INCH BY 18 INCH LAP SPONGES
• Common Device Name: 18 INCH BY 18 INCH LAP SPONGES
• Manufacturer (Section D): MEDICAL ACTION, INDUSTRIES, INC. ; mechanicsville VA 23116
• MDR Report Key: 6157674
• Report Number: MW5066601
• Device Sequence Number: 10866445
• Product Code: GDY
• UDI-Device Identifier: 10809160000106
• UDI-Public: (01)10809160000106
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2019
• Device Lot Number: 1601JK304A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR