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U.S. Department of Health and Human Services

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

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HOLOGIC, INC. SECURMARK TISSUE SITE MARKING SYSTEM Back to Search Results
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.
 
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Brand NameSECURMARK
Type of DeviceTISSUE SITE MARKING SYSTEM
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
Manufacturer Contact
kristin fornieri
36 & 37 apple ridge road
danbury, CT 06810
2037318491
MDR Report Key8527799
MDR Text Key142373105
Report Number1222780-2019-00089
Device Sequence Number1
Product Code NEU
UDI-Device Identifier15420045503618
UDI-Public15420045503618
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/28/2019
Device Model NumberSMARK-EVIVA-13
Device Catalogue NumberSMARK-EVIVA-13
Device Lot Number18L28RP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/18/2019 Patient Sequence Number: 1
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