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

Catalog Number 5062

Device Problems Product Quality Problem (1506); Material Split, Cut or Torn (4008)

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

Event Date 05/05/2019

Event Type  malfunction  

Event Description

Gloves tearing at base, fingers, etc while being applied.Multiple boxes, multiple lot numbers.Lot numbers include mth12-09, ceh 10-06, ceh 09-16, mth11-23, mth12-14, mth12-16, mth12-13, ceh 07-18, mth12-20.

• Brand Name: PREMIERPRO PLUS
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate place, suite 425; charlotte NC 28277
• MDR Report Key: 8793297
• MDR Text Key: 151134783
• Report Number: 8793297
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5062
• Device Lot Number: CEH 09-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2019
• Date Report to Manufacturer: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1