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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. SECURMARK BIOPSY SITE TISSUE MARKER DEVICE

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HOLOGIC, INC. SECURMARK BIOPSY SITE TISSUE MARKER DEVICE Back to Search Results
Model Number SMARK-U-SS2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 04/23/2019
Event Type  Injury  
Manufacturer Narrative
Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known. The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant. Internal complaint reference: (b)(4).
 
Event Description
It was reported that a patient had a biopsy procedure on (b)(6) 2019 and a biopsy marker was placed. The patient reported that side effects started within 2 days of the procedure, " i felt little bursts behind nipple within the following day waking up to dark purple bruising; approximately 2 inch by 3 inch hard lump swelling; kidneys aching, joint pain and inflammation both arms and legs, lips tingling and swelling. I didn't have any of the symptoms prior to core biopsy and breast marker placement. " the patient has followed up with her physician regarding these symptoms. The patient declined to provide any information on the site where the biopsy was performed. The biopsy results were negative for malignancy.
 
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Brand NameSECURMARK
Type of DeviceBIOPSY SITE TISSUE MARKER DEVICE
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 Key8659822
MDR Text Key146773363
Report Number1222780-2019-00136
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102768
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 05/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSMARK-U-SS2
Device Catalogue NumberSMARK-U-SS2
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/31/2019 Patient Sequence Number: 1
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