MAUDE Adverse Event Report: MEDLINE MEDLINE; SENSICARE GLOVES

Model Number MSG1070

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2017

Event Type  malfunction  

Event Description

Technician opened medline sensicare gloves size 7 and discovered them to have brown spotting on left hand.Item# msg1070, lot# 703934540470-5.Complaint reference# (b)(4).

• Brand Name: MEDLINE
• Type of Device: SENSICARE GLOVES
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 6851355
• MDR Text Key: 85606583
• Report Number: MW5072023
• Device Sequence Number: 1
• Product Code: LZC
• 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: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• 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 Model Number: MSG1070
• Device Lot Number: 703934540470-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1