MAUDE Adverse Event Report: MEDLINE SENSICARE SURGICAL GLOVE

Lot Number 705938579775-3

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

Patient Problem No Information (3190)

Event Date 10/09/2017

Event Type  malfunction  

Event Description

Medline size 7 sensicare gloves lot 706938579770-7, exp 05/2020, and medline size 7-1/2 sensicare surgical gloves lot: 705938579775-3, exp 04/2020, have black particles embedded within the gloves.Reason for use: for compounding.

• Brand Name: SENSICARE SURGICAL GLOVE
• Type of Device: SENSICARE SURGICAL GLOVE
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 6943835
• MDR Text Key: 89374593
• Report Number: MW5072723
• Device Sequence Number: 2
• 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: 10/10/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2020
• Device Lot Number: 705938579775-3
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1