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

Catalog Number	4010-02-15-T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient potentially suffered and allergic reaction after breast biopsy marker (hydromark) was inserted during the procedure.The patient attended the er with an anaphylactic allergic reaction.As the allergist was unfamiliar with our product and procedure the patient wanted to know more about the components of our product, so that they could be tested appropriately.Patient was provided with information on the hydrogel material.After following up for the clinical opinion on the pathologist and physician no response was received.Based on the information available we cannot confirm symptoms were a result of our device.Although we cannot confirm that the device caused the reported reaction, we are submitting this report due to the alleged allergic reaction.
Event or Problem Description
It was reported that on monday morning 13 september "i had a breast biopsy performed where the radiologist inserted one of your products - a breast biopsy site marker (hydromark).On monday afternoon i landed up in the emergency room with an anaphylactic allergic reaction.The allergist that i have been referred to is trying to rule out various possibilities, so as this was the only unfamiliar event of the day for me i would like to know what are the components of the hydromark.In other words, please would you inform me as to the metals that are in this product as i need to be tested to see if any of the substances are responsible for this serious allergic reaction.Please would you treat this as an urgent request.Thanks for prompt assistance with this (b)(6) no product information provided." allergic reaction has not been confirmed to be caused by our device.This event has been reported as complaint number (b)(4).
Additional Manufacturer Narrative
It was reported that the patient potentially suffered and allergic reaction after breast biopsy marker (hydromark) was inserted during the procedure.The patient attended the ed with an anaphylactic allergic reaction.As the allergist was unfamiliar with our product and procedure the patient wanted to know more about the components of our product, so that they could be tested appropriately.Patient was provided with information on the hydrogel material.After following up with the sales rep for the clinical opinion of the pathologist and physician no response was received.However, the patient was called and she stated that her doctor confirmed her reaction was not caused by our device.The clip is currently still implanted, and she stated she is no longer experiencing any symptoms of her reaction.Ifu was reviewed for effectiveness.The following was listed as a potential undesirable side effect: "hypersensitivity to any implant may occur.As with any implanted device, the implant site should be monitored for any signs of irritation or reaction following the surgical procedure." although the doctor confirmed the patient's reaction was not attributed to our device the instructions in the ifu were determined to be effective.No corrective action will be taken at this time.

• 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
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; parque industrial, tijuana 22440 ; MX 22440
• Manufacturer Contact: vivian rodriguez ; 300 e business way fifth floor; cincinnati, OH 45241
• MDR Report Key: 12643678
• Report Number: 3008492462-2021-00009
• Device Sequence Number: 1205473
• Product Code: NEU
• UDI-Device Identifier: 10841911100109
• UDI-Public: (01)10841911100109(17)240616(10)F12126332D
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2024
• Device Catalogue Number: 4010-02-15-T3
• Device Lot Number: F12126332D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown