inforMED
MalfunctionGDY

SPONGE

Received Sep 24, 2015 · Event occurred May 4, 2015

Report 5100470 · MDR key 5100470

Device

Generic name

Sponge

Manufacturer

Leesar, Inc.

Lot number

LSRHHVAGPEA

Product problems

  • Device Packaging Compromised

Patient

Not reported

  • No Information

Narrative

Description of Event or Problem

A PACK OF SPONGES IN THE VAGINAL PACK HAD 11 SPONGES INSTEAD OF 10. IDENTIFIED BY OPERATING ROOM STAFF DURING THE INITIAL COUNT FOR THE PROCEDURE. THE INCORRECT PACK OF SPONGES WAS REMOVED AND SENT TO OPERATING ROOM MATERIALS MANAGEMENT.