MAUDE Adverse Event Report: SVS LLC PREMIERPRO PLUS; POWDERED LATEX SURGEON'S GLOVES

Lot Number MTH11-17

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/16/2019

Event Type  malfunction  

Event Description

When nurse was putting on gloves, she felt debris in the tip of the glove on the middle finger, removed the glove and took the box of gloves out of service.Unable to determine the source of the debris.

• Brand Name: PREMIERPRO PLUS
• Type of Device: POWDERED LATEX SURGEON'S GLOVES
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate pl ste 425; charlotte NC 28277
• MDR Report Key: 9585991
• MDR Text Key: 174880214
• Report Number: 9585991
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: MTH11-17
• 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: 12/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1