FDA Adverse Event Injury Summary report: N

HENRY SCHEIN

MDR report key: 19229121 · Received May 2, 2024

Report

Report Number
2411236-2024-00004
Event Type
Injury
Date Received
May 2, 2024
Date of Event
October 1, 2023
Report Date
May 2, 2024
Manufacturer
PERUSAHAAN GETAH ASAS SDN. BHD.
Product Code
LZA
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
CA, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THE DOCTOR REPORTED THAT MULTIPLE PATIENTS COMPLAINED OF TENDER AND PAINFUL WOUNDS ON THEIR SCALP, FACE AND LEGS AND THE STAFF AT THE OFFICE HAS REPORTED EXPERIENCING UPPER RESPIRATORY INFECTIONS AND COLD SYMPTOMS CONTINUOUSLY STARTING IN (B)(6) 2023. PATIENTS DESCRIBED HAVING "HOT WOUNDS/OOZING", BODY ACHES AND FATIGUE AFTER MEDICAL OFFICE SKIN EXAMS, WOUND CHECKS, AND SURGICAL PROCEDURES. THE DOCTOR ALLEGED THAT THE PATIENT'S AND STAFF MEMBER'S SYMPTOMS ARE RELATED TO CONTACT WITH THE GLOVES. THE DOCTOR REPORTED USING A BLACK LIGHT ON THE BOXES OF GLOVES AND ALLEGED THAT THE GLOVES INSIDE HAVE "SPOTTING." THE PATIENT/STAFF AGE RANGES ARE BETWEEN 20'S-80'S, BOTH MALES AND FEMALES. MORE THAN 12 PATIENTS WERE ESTIMATED TO BE AFFECTED. THE CUSTOMER REPORTED SOME OF THE PATIENTS HAVE COMMON DRUG ALLERGIES, BUT THEY ARE NOT ALLERGIC TO THE GLOVES AND THE STAFF MEMBERS DO NOT HAVE ALLERGIES. THE GLOVES ARE STORED IN EXAM ROOMS CUPBOARDS, IN THE MEDICAL LAB WHERE OTHER MEDICAL SUPPLIES ARE STORED. THE PATIENTS AND STAFF MEMBERS WERE TREATED WITH TOPICAL AND ORAL ANTIBIOTICS. THE DOCTOR ALLEGED IT TYPICALLY TAKES TEN (10) DAYS OF ANTIBIOTIC COURSE FOR THE SYMPTOMS TO SUBSIDE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
457035 HENRY SCHEIN CRITERION NITRILE N200 EXAM GLOVES LZA PERUSAHAAN GETAH ASAS SDN. BHD. K2503309A02

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other