Model Number SMARK-EVIVA-13 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Skin Irritation (2076); Swelling (2091); Burning Sensation (2146)
|
Event Date 03/28/2019 |
Event Type
Injury
|
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 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.
|
|
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.
|
|
Search Alerts/Recalls
|