GELMARK ULTRA BREAST TISSUE MARKER

Additional Manufacturer Narrative

MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER WAS NOT PROVIDED. VISUAL INSPECTION: THE SAMPLE WAS NOT RETURNED; THEREFORE, A VISUAL INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: THE SAMPLE WAS NOT RETURNED; THEREFORE, A FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT ISSUES CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. 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 APPROXIMATELY EIGHT MONTHS AFTER BREAST TISSUE MARKER PLACEMENT THE PATIENT ALLEGEDLY DEVELOPED CONTACT DERMATITIS AND HIVES TO VARYING DEGREES. ANTI-HISTAMINE AND ANTI-INFLAMMATORY MEDICATIONS HAVE NOT RESOLVED HER SYMPTOMS, ALTHOUGH SHE HAS RECEIVED CORTISONE SHOTS, XOLAIR, AND ANTI-HISTAMINE TABLETS. THE HEALTH CARE PROVIDER WHO PLACED THE BREAST TISSUE MARKER PLANS TO EXPLANT THE DEVICE. ADDITIONAL INFORMATION: THE HEALTH CARE PROVIDER REMOVED THE BREAST TISSUE MARKER. TWO WEEKS POST REMOVAL PROCEDURE, THE PATIENT CLAIMED THE REPORTED SKIN REACTIONS WERE 90% RESOLVED.

Additional Manufacturer Narrative

MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER WAS NOT PROVIDED. VISUAL INSPECTION: THE SAMPLE WAS NOT RETURNED; THEREFORE, A VISUAL INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: THE SAMPLE WAS NOT RETURNED; THEREFORE, A FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT ISSUES CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. 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 APPROXIMATELY EIGHT MONTHS AFTER BREAST TISSUE MARKER PLACEMENT THE PATIENT ALLEGEDLY DEVELOPED CONTACT DERMATITIS AND HIVES TO VARYING DEGREES. ANTI-HISTAMINE AND ANTI-INFLAMMATORY MEDICATIONS HAVE NOT RESOLVED HER SYMPTOMS, ALTHOUGH SHE HAS RECEIVED CORTISONE SHOTS, XOLAIR, AND ANTI-HISTAMINE TABLETS. THE HEALTH CARE PROVIDER WHO PLACED THE BREAST TISSUE MARKER PLANS TO EXPLANT THE DEVICE.