MAUDE Adverse Event Report: HOLOGIC, INC. SECURMARK; TISSUE SITE MARKING SYSTEM

Model Number	SMARK-EVIVA-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Irritation (2076); Swelling (2091); Burning Sensation (2146)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned product investigation is still in-process as of today, a follow-up will be filed as needed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that two technologists were setting up a tray for a stereotactic biopsy, the last thing they opened was the package to the securmark marker and seconds after they noted buring and white marks on their fingers.Additional information received from the customer later that same day noted the white coloring was fading, but some swelling and tingling sensation remained.The technologists had applied ice to the affected area and used rubbing alcohol and hydrogen peroxide on the white markings.They were evaluated by employee health, but no medical intervention was given.It was noted that the technologists were not wearing gloves while handling the packaging.A second customer follow-up was made on (b)(6) 2019 and it was reported that the white marks had disappeared and the swelling went down.
Additional Manufacturer Narrative
An evaluation of the returned sample was completed and the substance in question was chemically characterized and compared against known chemicals in the manufacturing process.A definitive cause of of the contamination cannot be determined at this time.No match was obtained during testing, noting that the contaminant may have occurred after shipment.

• Brand Name: SECURMARK
• Common Device Name: TISSUE SITE MARKING SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8527799
• Report Number: 1222780-2019-00089
• Device Sequence Number: 16612111
• Product Code: NEU
• UDI-Device Identifier: 15420045503618
• UDI-Public: 15420045503618
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 11/28/2019
• Device Model Number: SMARK-EVIVA-13
• Device Catalogue Number: SMARK-EVIVA-13
• Device Lot Number: 18L28RP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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