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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FOCAL THERAPEUTICS "BIOSORB" MARKER, RADIOGRAPHIC, IMPLANTABLE

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FOCAL THERAPEUTICS "BIOSORB" MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Lot Number J2-190610
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Inflammation (1932); Pain (1994)
Event Date 10/22/2020
Event Type  Injury  
Event Description
Patient had biosorb cavity implant inserted on (b)(6) 2020, pt developed redness, tenderness, no fever. Placed on antibiotics with no change, redness increased. Biosorb implant surgically removed on (b)(6) 2020. Fda safety report id # (b)(4).
 
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Brand Name"BIOSORB"
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
FOCAL THERAPEUTICS
MDR Report Key10770457
MDR Text Key214360578
Report NumberMW5097599
Device Sequence Number1
Product Code NEU
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberJ2-190610
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/30/2020 Patient Sequence Number: 1
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