MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC HYDROMARK BREAST BIOPSY SITE MARKER; BIOPSY SITE IDENTIFIER

Model Number	4010-02-15-T1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and mri.It was reported by a patient on (b)(6) 2020, "i had one of your clips implanted after a breast biopsy in (b)(6).10 days later i had and infection that was treated for 20 days.I still have redness around the surgical site.At this point in time i am wondering if i am having an allergic reaction to the clip and or the gel that is around the clip that was implanted and i need to have further information on the product.Model # 4010-02-15-t1." after reaching out for more information concerning the allegation of an allergic reaction, the patient stated that she is an allergic person and not sure if she is allergic to titanium.The doctor could not confirm what caused the redness on her breast but did prescribe the patient antibiotics.The patient is no longer on the antibiotics and not further treatment was given.She mentioned she will be looking into testing if she is allergic to titanium in the future.
Event or Problem Description
On (b)(6) 2020 the following was reported by a patient," "i had one of your clips implanted after a breast biopsy in (b)(6).10 days later i had and infection that was treated for 20 days.I still have redness around the surgical site.At this point in time i am wondering if i am having an allergic reaction to the clip and or the gel that is around the clip that was implanted and i need to have further information on the product.Model # 4010-02-15-t1." this event was documented as complaint #(b)(4).

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• Common Device Name: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 10830115
• Report Number: 3008492462-2020-00009
• Device Sequence Number: 4141117
• Product Code: NEU
• UDI-Device Identifier: 10841911100093
• UDI-Public: (01)10841911100093(17)220905(10)F11938435D
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K130537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: 4010-02-15-T1
• Device Lot Number: F11938435D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other