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 Codes	Hypersensitivity/Allergic reaction (1907); Reaction (2414); Patient Problem/Medical Problem (2688)
Date of Event	01/27/2020
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 that after an ultrasound biopsy with a hydromark marker, product code 4010-02-15-t3, caused a reaction in the patient.The patient experienced redness and pain to the breast.No testing on the specific device has been conducted as the device was not returned for evaluation.However, sensitivity, cytoxicity and other reaction testing was conducted as part of the initial qualification of this device.No known reactions similar to those reported in this event were reported during this testing.Although it could not be concluded that our device caused or contributed to this event, due to the reported adverse event this has been determined to be reportable pursuant to 21 cfr 803.As such, we are submitting this medwatch report.
Event or Problem Description
It was reported by sales representative after procedure, st modality, a patient - had a reaction post biopsy.Patient complication details: redness and pain to the breast - sent to the er.The customer did not provide the necessary information to determine the severity of harm of the alleged injury.Devicor is reporting on the allegation of injury only.If any new additional relevant information is identified, the injury will be characterized accordingly.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
• MDR Report Key: 9748405
• Report Number: 3008492462-2020-00003
• Device Sequence Number: 19599953
• Product Code: NEU
• UDI-Device Identifier: 10841911100109
• UDI-Public: (01)10841911100109(17)221106(10)F11948401D
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 11/06/2022
• 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: 01/29/2020
• Initial Report FDA Received Date: 02/24/2020
• 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