MAUDE Adverse Event Report: THERAMESH; SOURCE, BRACHYTHERAPY, RADIONUCLIDE

Model Number	XX7210SM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with the theragenics theramesh on (b)(6) 2021.An infection developed at the treatment site.There is a plan to explant the device.Fda safety report id# (b)(4).

• Brand Name: THERAMESH
• Common Device Name: SOURCE, BRACHYTHERAPY, RADIONUCLIDE
• MDR Report Key: 12391887
• Report Number: MW5103589
• Device Sequence Number: 5131086
• Product Code: KXK
• UDI-Device Identifier: 00813787020853
• UDI-Public: 00813787020853
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: XX7210SM
• Device Lot Number: X21-9117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): No Information
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR