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

Model Number 4010-02-15-T3

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 09/17/2019

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 that after an ultrasound biopsy with a hydromark marker, product code 4010-02-15-t3, the patient developed a rash. 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 Description

It was reported by a representative that after a us biopsy with hm patient developed a rash. "the procedure was completed with the original device. Patient complications: yes, patient developed a rash after us biopsy with hm. " this incident has been recorded in 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: rhonda kops ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 9177286
• Report Number: 3008492462-2019-00047
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 4010-02-15-T3
• Device Catalogue Number: 4010-02-15-T3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Other