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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L. BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE

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HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L. BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Patient Problems Breast Mass (2439); Breast Discomfort/Pain (4504)
Event Date 07/27/2018
Event Type  Injury  
Event Description
I underwent a lumpectomy for a malignant breast tumor. Prior to surgery biozorb was discussed and i told dr i did not want a biozorb placed in me. Day of surgery surgeon has a problem finding the tumor and excised excessive amount of tissue while attempting to find it. Surgeon then placed a biozorb in me to fill the void created by excising too much tissue. Biozorb was very painful, my skin pulled in around it, and then had to be removed on (b)(6) 2018. I still have pain in the area were the biozorb was. Breast implants post biozorb removal. Fda safety report id#: (b)(4).
 
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Brand NameBIOZORB
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L.
MDR Report Key11640783
MDR Text Key244868118
Report NumberMW5100665
Device Sequence Number1
Product Code NEU
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/08/2021 Patient Sequence Number: 1
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