MAUDE Adverse Event Report: SVS LLC PREMIERPRO; DRAPE, SURGICAL

Model Number	8326B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The sterile or towels from premierpro are having an issue with extra lint that is transferring to wires when wet.Lots of lint coming off towels.
Event or Problem Description
The sterile operation room towels from premierpro are having an issue with extra lint that is transferring to wires when wet.Lots of lint coming off towels.

• Brand Name: PREMIERPRO
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): SVS LLC; 13034 ballantyne corporate pl; charlotte NC 28277
• MDR Report Key: 25092856
• Report Number: 25092856
• Device Sequence Number: 10749164
• Product Code: KKX
• UDI-Device Identifier: 00818566010193
• UDI-Public: (01)00818566010193
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026
• Report Date (Section F): 04/23/2026

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?: No
• Device Model Number: 8326B
• Device Catalogue Number: 8326B
• Device Lot Number: CBBP12-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/06/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 04/23/2026