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

Model Number XX7210SM

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 08/25/2021

Event Type  Injury  

Event 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
• Type of Device: SOURCE, BRACHYTHERAPY, RADIONUCLIDE
• Manufacturer (Section D): THERAGENICS CORPORATION; buford GA 30518
• MDR Report Key: 12391887
• MDR Text Key: 269337138
• Report Number: MW5103589
• Device Sequence Number: 1
• Product Code: KXK
• UDI-Device Identifier: 00813787020853
• UDI-Public: 00813787020853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: XX7210SM
• Device Lot Number: X21-9117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR