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

Catalog Number 5063

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2019

Event Type  malfunction  

Event Description

Gloves ripped.

• Brand Name: PREMIER PRO PLUS
• Type of Device: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate pl ste 425; charlotte NC 28277
• MDR Report Key: 9165651
• MDR Text Key: 161522096
• Report Number: 9165651
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5063
• Device Lot Number: MTI04-13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1