GATTEX

Additional Manufacturer Narrative

THE COMPLAINT SAMPLE AND LOT NUMBER IS NOT AVAILABLE FOR RETURN. SINCE THERE IS INSUFFICIENT INFORMATION FOR FOLLOW-UP, FURTHER INVESTIGATION IS NOT POSSIBLE.

Description of Event or Problem

FIELD NURSE STATES PATIENT IS REPORTING "AN ENLARGED STOMA, NAUSEA, BLOATING, CRAMPING, WEIGHT GAIN, AND DECREASED OUTPUT." PATIENT IS REACHING OUT TO HCP TO NOTIFY. NO ADDITIONAL INFORMATION PROVIDED. PER FIELD NURSE PATIENT IS "HAVING DIFFICULTY WITH THE DOSING SYRINGE NEEDLE AND HAS CONTAMINATED THE NEEDLE BY TWISTING IT TOO MUCH TO THE SYRINGE OR NOT ENOUGH". ALSO, THE PATIENT WAS "UNABLE TO DRAW UP THE CORRECT DOSE BECAUSE THERE WAS NOT ENOUGH LIQUID, SO THE PATIENT HAD TO WASTE THOSE SUPPLIES AND START THE PROCESS OVER WITH NEW SUPPLIES." SPECIALTY PHARMACY IS UNIVERSITY OF ROCHESTER STRONG MEMORIAL HOSPITAL PHARMACY. PRODUCT IS NOT AVAILABLE FOR RETURN.