inforMED
MalfunctionKIP

BALANCED SALT SOLUTION

Received Jan 7, 2013 · Event occurred Oct 18, 2012

Report 9614546-2013-00002 · MDR key 2898216

Device

Generic name

Surgical Adjuncts

Model number

ENDOSOL

Catalog number

BALANCED SALT SOLUTION

Lot number

12G1604

Product problems

  • Tear, Rip or Hole in Device Packaging

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

WE RECEIVED A REPORT THAT A BOTTLE OF BALANCED SALT SOLUTION FELL TO THE FLOOR AFTER THE HANGER FAILED DURING A SURGICAL PROCEDURE. THERE WAS NO INJURY TO THE PATIENT OR THE DOCTOR.

Additional Manufacturer Narrative

(B)(6). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.