MAUDE Adverse Event Report: MEDLINE MEDLINE SENSICARE SLT SURGICAL GLOVES

Catalog Number MSG1570

Device Problem Material Integrity Problem (2978)

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/25/2017

Event Type  Injury  

Event Description

Medline sensicare slt surgical gloves size 7.We had 4 instances where the glove integrity was compromised on the left index finger and exposed two healthcare professionals to blood and body fluids.(surgeon and nurse).

• Brand Name: MEDLINE SENSICARE SLT SURGICAL GLOVES
• Type of Device: SURGICAL GLOVE
• Manufacturer (Section D): MEDLINE; mundelein IL 60060
• MDR Report Key: 6753657
• MDR Text Key: 81501761
• Report Number: MW5071285
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: MSG1570
• Device Lot Number: 703915720270
• 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
• Patient Outcome(s): Other