MAUDE Adverse Event Report: PATTERSON DENTAL SUPPLY INC PATTERSON® TACTILEGUARD ULTRA 3G¿ NITRILE EXAM GLOVES; MEDICAL GLOVE, SPECIALTY

Catalog Number 131-1786

Patient Problems Sore Throat (2396); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Doctor wasn't feeling well and took amoxicillin.He started working using the patterson gloves for the first time and experienced an adverse event.His fingers started tingling and swelled up, and his throat began to itch.He drove himself to the doctor's office, where they called an ambulance and administered two doses of epinephrine.This ultimately resulted in a hospital stay.Reference report: mw5152858.

• Brand Name: PATTERSON® TACTILEGUARD ULTRA 3G¿ NITRILE EXAM GLOVES
• Type of Device: MEDICAL GLOVE, SPECIALTY
• Manufacturer (Section D): PATTERSON DENTAL SUPPLY INC; st. paul MN 55120
• MDR Report Key: 18911820
• MDR Text Key: 337927209
• Report Number: MW5152857
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 131-1786
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: AMOXICILLIN.
• Patient Outcome(s): Other; Hospitalization