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

Model 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	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient experienced a potential allergic reaction after the biopsy breast marker (hydromark) was inserted in the morning and subsequently developed diffuse urticarial type rash over the body and shortness of breath in the evening.Patient attended ed department for investigation - symptoms resolved, treatment for reaction (urticaria) was not specified and treatment for reaction (shortness of breath) was not specified.Based on the information available we cannot confirm symptoms were a result of our device, however, current ifu identifies the potential for foreign body reaction with use of hydromark markers.As with any implanted device, the implant site should be monitored for any signs of irritation or reaction following the surgical procedure.Although we cannot confirm that the device caused the reported reaction we are submitting this report due to the medical attention that was received.
Event or Problem Description
It was reported that the patient experienced a potential allergic reaction after the biopsy breast marker (hydromark) was inserted in the morning and subsequently developed diffuse uticarial type rash over the body and shortness of breath in the evening.Patient attended ed department for investigation - symptoms resolved, treatment for reaction (uticaria) was not specified and treatment for reaction (shortness of breath) was not specified.This incident has been recorded in 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: 11572811
• Report Number: 3008492462-2021-00003
• Device Sequence Number: 14333084
• Product Code: NEU
• UDI-Device Identifier: 10841911102158
• UDI-Public: (01)10841911102158(17)210811(10)F12034102D
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 08/11/2021
• Device Model Number: 4010-02-15-T3
• Device Catalogue Number: 4010-02-15-T3
• Device Lot Number: F11948401D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/25/2021
• 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