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

Catalog Number CUR8234

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 02/26/2014

Event Type  Injury  

Event Description

The end user developed a rash after wearing the gloves.

Manufacturer Narrative

It was reported that the end user developed a rash on her hands after wearing the gloves.She sought medical attention and was prescribed oral steroids.No serious injury resulted.The sample was not returned for evaluation.We have no trend for irritation issues related to use of this glove.

• Brand Name: 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: 3833423
• MDR Text Key: 20016673
• Report Number: 1417592-2014-00048
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CUR8234
• Device Lot Number: MA306619010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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