MAUDE Adverse Event Report: MEDLINE MEDLINE SENSICARE GLOVES

Catalog Number MSG1075

Device Problem Material Integrity Problem (2978)

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

Event Date 08/25/2017

Event Type  malfunction  

Event Description

Technician opened medline sensicare gloves size 7.5 and discovered them to have brown scuff mark on right hand pinky.Item # msg1075, lot # 703934540475-3.

• Brand Name: MEDLINE SENSICARE GLOVES
• Type of Device: SENSICARE GLOVES
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 6843369
• MDR Text Key: 84967570
• Report Number: MW5071958
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/31/2017

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 Expiration Date: 02/29/2020
• Device Catalogue Number: MSG1075
• Device Lot Number: 703934540475-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• 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