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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 F303
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Infection (4544)
Event Type  Injury  
Event Description
It was reported that 2 years after a patient received a biozorb marker, an infection occurred at the site of the marker. The patient received a surgery to remove the marker and pieces of material were found at the infection site. Exact date was not available. 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
MDR Report Key12754260
MDR Text Key282494415
Report Number1222780-2021-00315
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
PMA/PMN Number
K143484
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberF303
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/04/2021 Patient Sequence Number: 1
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