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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC SMARK-ATEC BREAST BIOPSY MARKER

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HOLOGIC, INC SMARK-ATEC BREAST BIOPSY MARKER Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
Lot number of the 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 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 lot number was not provided by the complainant. If additional relevant information is received, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported a physician performed an atec breast biopsy procedure on (b)(6) 2016 and placed a smart marker. The patient was discharged home. Sometime post procedure, the patient returned to the medical office "complaining of systemic reaction all over". It is unknown if intervention was required. Attempts are being made to obtain additional information.
 
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Brand NameSMARK-ATEC
Type of DeviceBREAST BIOPSY MARKER
Manufacturer (Section D)
HOLOGIC, INC
250 campus drive
marlborough MA 01752
Manufacturer Contact
craig callahan
250 campus drive
marlborough, MA 01752
5082638859
MDR Report Key6047894
MDR Text Key58098515
Report Number1222780-2015-00252
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K07293
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 09/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received09/23/2016
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: 10/21/2016 Patient Sequence Number: 1
Treatment
ATEC HAND PIECE - LOT# UNK
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