MAUDE Adverse Event Report: SVS LLC PREMIERPRO PLUS; GLOVES

Lot Number MTI04-13

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/06/2019

Event Type  malfunction  

Event Description

Gloves from box are ripping.This is a recurring problem at our hospital.

• Brand Name: PREMIERPRO PLUS
• Type of Device: GLOVES
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate place, suite 425; charlotte NC 28277
• MDR Report Key: 9081637
• MDR Text Key: 158983679
• Report Number: 9081637
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 08/23/2019
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1