MAUDE Adverse Event Report: SVS LLC PREMIERPRO PLUS; POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE

Model Number	5063
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Glove tore when putting on during case.Recurring problem.

• Brand Name: PREMIERPRO PLUS
• Common Device Name: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate place, suite 425; charlotte NC 28277
• MDR Report Key: 8926207
• Report Number: 8926207
• Device Sequence Number: 16676283
• Product Code: LZC
• UDI-Device Identifier: 00818566011022
• UDI-Public: (01)00818566011022
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/01/2019
• Report Date (Section F): 08/01/2019

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: No Information
• Device Model Number: 5063
• Device Catalogue Number: 5063
• Device Lot Number: MTH12-16
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/01/2019