SILICONE DRAIN
Received Sep 29, 2010 · Event occurred Sep 27, 2010
Report MW5017653 · MDR key 1852957
Device
Generic name
Silicone Drain
Manufacturer
Medline Industries, Inc.Model number
19F, ENDLot number
P0816311
Product problems
- Break
- Detachment Of Device Component
- Difficult to Remove
Patient
62 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
PATIENT HAD UNDERGONE VENTRAL HERNIA REPAIR ON (B)(6)2010 AT (B)(6) MEDICAL CENTER. ONE SILICONE 19F DRAIN WAS PURPOSEFULLY LEFT IN PLACE. THE PATIENT WAS TRANSFERRED TO A LONG TERM ACUTE CARE FACILITY -PROMISE SUBURBAN- WITH THE DRAIN INTACT. ON (B)(6)2010, AT THE LONG TERM FACILITY, THE DRAIN WAS REMOVED. AT THE TIME OF REMOVAL A PART OF THE DRAIN, APPROXIMATELY 15.2 CM, WAS UNINTENTIONALLY RETAINED. ON (B)(6)2010, THE PATIENT PRESENTED TO (B)(6) EMERGENCY DEPARTMENT WITH 3 DAY HISTORY OF ABDOMINAL PAIN. SHE WAS ADMITTED AND THE RETAINED DRAIN PIECE -IDENTIFIED ON CT SCAN- WAS SURGICALLY REMOVED. UPON INSPECTION, THE PIECE APPEARED TO HAVE ONE END THAT WAS JAGGED AND UNEVEN, AS IF IT HAD BEEN TORN APART.