MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC PROTEXIS PI SIZE 7; SURGEON'S GLOVES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Burning Sensation (2146); Caustic/Chemical Burns (2549)

Event Date 07/06/2020

Event Type  malfunction  

Event Description

Health care worker was assisting with a special procedure and went to put on sterile gloves.She felt a burning sensation to her right thumb and felt like she had a cut on her thumb area.She took the gloves off and there was a chemical burn looking area to the right thumb, with swelling and redness to hand.

• Brand Name: PROTEXIS PI SIZE 7
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11228724
• MDR Text Key: 239462851
• Report Number: 11228724
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2021,07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2021
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9125 DA