MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. STRETCH VINYL EXAM GLOVE

Catalog Number FG1501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Date 06/13/2014

Event Type  Injury  

Event Description

The end user developed a rash after wearing the gloves and was treated with prednisone.

Manufacturer Narrative

While wearing the gloves, a dietary employee experienced itching of her hands which then spread to other areas of her body.Prednisone was prescribed.The gloves had recently been introduced into this department.It is not known if there may have been other contributing factors in the department that may have caused this irritation.Due to the need for medical intervention and in an abundance of caution, this medwatch is being filed.

• Brand Name: STRETCH VINYL EXAM GLOVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 3981184
• MDR Text Key: 20108341
• Report Number: 1417592-2014-00073
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FG1501
• Device Lot Number: JJ406907512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR