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	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When opening a pack of sterile single use towels, debris of unknown origin, similar to hair, was found in the weave of the towel.

• Brand Name: PREMIERPRO
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): SVS LLC; 13034 ballantyne corporate pl; charlotte NC 28277
• MDR Report Key: 17806928
• Report Number: 17806928
• Device Sequence Number: 6692117
• Product Code: KKX
• UDI-Device Identifier: 00818566010193
• UDI-Public: (01)00818566010193(17)270901(10)CBBL09-04
• 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): 06/26/2023
• Report Date (Section F): 06/26/2023

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: 8326B
• Device Catalogue Number: 8326B
• Device Lot Number: CBBL09-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2023
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/26/2023