MAUDE Adverse Event Report: VINYL GLOVES ; VINYL PATIENT EXAMINATION GLOVE

Lot Number JCU608397064

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Event Description

Topcare's vinyl gloves (bar code 036800185531, lot jcu608397064) and its nitrile gloves (bar code 036800185524, lot mh608404567) allow liquid to pass through.But they are sold as being "great for first aid, health care." i am a personal care aide (home healthcare aide), and i noticed this while on assignment with a child with special needs, changing diapers.Topcare, cn.Fda safety report id# (b)(4).

• Brand Name: VINYL GLOVES
• Type of Device: VINYL PATIENT EXAMINATION GLOVE
• MDR Report Key: 8675065
• MDR Text Key: 147450765
• Report Number: MW5087173
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: JCU608397064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1