MAUDE Adverse Event Report: SVS LLC PREMIERPRO; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	X8435
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The pack of laps was noted to be missing the blue loops.

• Brand Name: PREMIERPRO
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate; pl suite 425; charlotte NC 28277
• MDR Report Key: 24639326
• Report Number: 24639326
• Device Sequence Number: 9786542
• Product Code: GDY
• UDI-Device Identifier: 00818566010582
• UDI-Public: (01)00818566010582(17)301201(10)CBBP12-01
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2026
• Report Date (Section F): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: X8435
• Device Catalogue Number: X8435
• Device Lot Number: CBBP12-01
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Date Report Sent to FDA: 03/13/2026