MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRICS, 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	11/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to the patient's surgical procedure, the initial lap sponge count was performed and each lap sponge had a ring attached to it.At the conclusion of the procedure, during the final count and prior to closure, one lap pad was found to be missing its ring.The patient's abdomen was inspected and the ring was located and removed.

• Brand Name: 18 INCH BY 18 INCH LAP SPONGES
• Common Device Name: 18 INCH BY 18 INCH LAP SPONGES
• Manufacturer (Section D): MEDICAL ACTION INDUSTRICS, INC.; mechanicsville VA 23116
• MDR Report Key: 6157709
• Report Number: MW5066602
• Device Sequence Number: 415781
• 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?: No
• 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: 33 YR