GEL MARK ULTRA BREAST TISSUE MARKER
Received Jun 2, 2025 · Event occurred May 7, 2025
Report 2020394-2025-00823 · MDR key 22121900
Device
Generic name
Biopsy Instrument
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
UNK GEL MARK ULTRA
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT 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. H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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 BD.
Description of Event or Problem
ON (B)(6) 2024, A FEMALE UNDERWENT A MARKER PLACEMENT PROCEDURE USING GEL MARK ULTRA. SOMETIME POST-PROCEDURE THE PATIENT ALLEGEDLY HAS SKIN PROBLEMS DISCOVERED THEY HAD ALSO HAD A NICKEL ALLERGY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.