MAUDE Adverse Event Report: CARDINAL HEALTH ESTEEM STRETCHY NITRATE; VINYL PATIENT EXAMINATION GLOVE

Model Number 8817NB

Device Problem Device Emits Odor (1425)

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

Event Date 12/08/2017

Event Type  malfunction  

Event Description

Rn removed glove from box and donned glove in usual fashion.Rn verbalized "gritty" sensation in glove.Glove removed and examined to find large brown foul foreign body.

• Brand Name: ESTEEM STRETCHY NITRATE
• Type of Device: VINYL PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): CARDINAL HEALTH; dublin OH 43017
• MDR Report Key: 7112091
• MDR Text Key: 94814919
• Report Number: MW5073933
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

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 Model Number: 8817NB
• Device Lot Number: 9C17K002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• 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