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

Model Number 4010-02-15-T1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/14/2020

Event Type  Injury  

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 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
• Type of Device: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; parque industrial, tijuana 22440 ; MX 22440
• Manufacturer Contact: jack cummings ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 10830115
• MDR Text Key: 215942422
• Report Number: 3008492462-2020-00009
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 10841911100093
• UDI-Public: (01)10841911100093(17)220905(10)F11938435D
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other