MAUDE Adverse Event Report: SEMPERMED USA, INC. STARMED ULTRA NITRILE GLOVES; SURGEON'S GLOVES

Catalog Number SMTN253

Device Problems Defective Device (2588); Material Split, Cut or Torn (4008)

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

Event Date 03/01/2019

Event Type  malfunction  

Event Description

Gloves are ripping/ tearing when pulled from box.2 boxes of defective gloves removed from service.Manufacturer response for ultra nitrile gloves, starmed ultra nitrile gloves size medium (per site reporter).Sales representative for sempermed contacted regarding equipment failure.Defective gloves same ref# and lot # from previous visit have been submitted to manufacturer for evaluation.Thus, no need to send additional samples or boxes of gloves.

• Brand Name: STARMED ULTRA NITRILE GLOVES
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): SEMPERMED USA, INC.; 13900 49th street north; clearwater FL 33762
• MDR Report Key: 8539287
• MDR Text Key: 142736820
• Report Number: 8539287
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMTN253
• Device Lot Number: L025193 1804
• 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: 04/22/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1