GELMARK ULTRA BREAST TISSUE MARKERS

Additional Manufacturer Narrative

AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

Description of Event or Problem

IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED AN ALLERGIC REACTION (RASH OVER NECK AND FACE). IT WAS FURTHER REPORTED THAT THE GENERAL PRACTITIONER COMMENCED PREDNISONE. REPORTEDLY, AFTER TESTING, THE IMMUNOLOGIST HAD PREDNISONE CEASED AND ANTIHISTAMINE COMMENCED. IT WAS FURTHER REPORTED THAT THE ANTIHISTAMINE WAS ABLE TO RESOLVE THE REACTION AND THE MARKER REMAINS IN PLACE.