MAUDE Adverse Event Report: WRP ASIA PACIFIC SDN. BHD. HENRY SCHEIN; CRITERION LATEX SURGICAL GLOVE

Catalog Number 570-2104

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

Patient Problem Rash (2033)

Event Date 06/16/2023

Event Type  Injury  

Event Description

A 28 year old female assistant had put latex gloves on and experienced a rash where the gloves touched her hands as well as a feeling of tightness in her chest.As a result she had to be administered epinephrine while at the office to help treat.As of today the female assistant is doing better.

• Brand Name: HENRY SCHEIN
• Type of Device: CRITERION LATEX SURGICAL GLOVE
• Manufacturer (Section D): WRP ASIA PACIFIC SDN. BHD.; lot 1, jalan 3; kawasan perusaahan bandar baru; salak tinggi, selangor 43900 ; MY 43900
• MDR Report Key: 17320506
• MDR Text Key: 319098066
• Report Number: 2411236-2023-00002
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/13/2023,06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 570-2104
• Device Lot Number: W102690365
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2023
• Distributor Facility Aware Date: 06/19/2023
• Event Location: Other
• Date Report to Manufacturer: 07/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female