MAUDE Adverse Event Report: ADVENTA HEALTH SDN BHD MCKESSON BRANDS; GLOVE, SURG SYN PF WHT TPE SZ75

Catalog Number 14-92075

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Type  malfunction  

Event Description

Customer reported that the gloves were donned and in less than 10 minutes caused hives and a rash.Customer required a steroid injection, allergy eye drops, benadryl, and a histamine blocker.

• Brand Name: MCKESSON BRANDS
• Type of Device: GLOVE, SURG SYN PF WHT TPE SZ75
• Manufacturer (Section D): ADVENTA HEALTH SDN BHD; no.1, jalan 8, pengkalan chepa; kota bahru, kelantan 16100 ; MY 16100
• MDR Report Key: 12592758
• MDR Text Key: 275254471
• Report Number: 1451040-2021-00020
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-92075
• Device Lot Number: MADJ08-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2021
• Distributor Facility Aware Date: 09/15/2021
• Device Age: 14 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other