MAUDE Adverse Event Report: SEMPERMED USA, INC. STARMED ULTRA NITRILE EXAM GLOVE; MEDICAL GLOVES WITH CHEMOTHERAPY LABELING CLAIMS

Lot Number L072306

Device Problems Device Damaged Prior to Use (2284); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

When the starmed ultra nitrile exam gloves were removed from box, it was evident that they were ¿ripped¿ in box- prior to removal.Two separate events.(1) a glove was removed from the box and the medial part of the glove was ripped.Mfg date/lot # 2020-12, l072306, 2021 (have the box and glove) size large.(2) a glove was removed from the box already ripped.Mfg date/lot # 2021-02, l076327, 2102 (not saved).(b)(6).Will look into the recurrent issues.

• Brand Name: STARMED ULTRA NITRILE EXAM GLOVE
• Type of Device: MEDICAL GLOVES WITH CHEMOTHERAPY LABELING CLAIMS
• Manufacturer (Section D): SEMPERMED USA, INC.; 13900 49th street north; clearwater FL 33762
• MDR Report Key: 12331134
• MDR Text Key: 266905794
• Report Number: 12331134
• Device Sequence Number: 1
• Product Code: OPJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: L072306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1