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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE

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HOLOGIC, INC. BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number F0221
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Erosion (2075)
Event Type  Injury  
Event Description
It was reported that a patient received a biozorb 18 months prior and ¨could still feel a lump¨, and it was determined that the marker had migrated and that it had eroded the skin. Because of this the physician decided to remove the marker. No other information is available.
 
Manufacturer Narrative
Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are 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. The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed. We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined. The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends. If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
 
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Brand NameBIOZORB
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough, MA 01752
Manufacturer (Section G)
HOLOGIC, INC.
250 campus drive
marlborough, MA 01752
Manufacturer Contact
daniel guevara
562 parkway
coyol free zone building b24
san jose, alajuela 20102- CRI
CS   20102 CRI
MDR Report Key12775213
MDR Text Key282336797
Report Number1222780-2021-00325
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberF0221
Was Device Available for Evaluation? No
Date Manufacturer Received10/26/2021
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: 11/08/2021 Patient Sequence Number: 1
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