MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC PROTEXIS; SURGEONS GLOVES

Model Number 2D72LT90

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2020

Event Type  malfunction  

Event Description

Surgeon noted tear between thumb and first finger on the cardinal health 200 protexis sterile latex powder-free surgical gloves during a surgical case.The gloves were changed several times, but the new pairs had the same issues.

• Brand Name: PROTEXIS
• Type of Device: SURGEONS GLOVES
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 10754895
• MDR Text Key: 213660158
• Report Number: 10754895
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2020

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: No Information
• Device Model Number: 2D72LT90
• Device Catalogue Number: 2D72LT90
• Device Lot Number: TS1910081, TS20020101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2020
• Date Report to Manufacturer: 10/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA