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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 F203
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 09/02/2021
Event Type  Injury  
Manufacturer Narrative
Lot and serial number of the device provided by the complainant are not adequate; 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 adequate. 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.
 
Event Description
It was reported that on a unknown date, a biozorb marker was placed but 2 weeks after the device had to be removed due to signs of infection. The patient received antibiotics for the infection. No other marker was placed again and a drain was placed. The patient was stable after the procedure. No other information is available.
 
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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 Key12543838
MDR Text Key273801986
Report Number1222780-2021-00291
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143484
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberF203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
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: 09/28/2021 Patient Sequence Number: 1
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