MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. SENSICARE PI GREEN SURGICAL GLOVES; SURGEON'S GLOVES

Model Number MSG9270

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/23/2019

Event Type  malfunction  

Event Description

Sterile medline sensicare pl green surgical gloves have small bug molded into the synthetic polyisoprene material.Photo available, but unable to download into report.(not an indicated format).Fda safety report id # (b)(4).

• Brand Name: SENSICARE PI GREEN SURGICAL GLOVES
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; northfield IL 60093
• MDR Report Key: 8842749
• MDR Text Key: 152796872
• Report Number: MW5088499
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: MSG9270
• Device Lot Number: 8109105670-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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