FDA Adverse Event Summary report: N

J & J

MDR report key: 210323 · Received February 17, 1999

Report

Report Number
MW1015692
Date Received
February 17, 1999
Report Date
February 8, 1999
Manufacturer
JOHNSON & JOHNSON MEDICAL DIV. OF ETHICON, INC.
Product Code
LYY
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
DENTIST

Narratives

Description of Event or Problem · 1

GLOVES FROM J & J MEDICAL ARE OFTEN DISCOVERED WITH HOLES IN THEM. THERE IS NO WAY TO TELL HOW MANY HAVE HOLES WHICH WERE NOT NOTED, BUT THE PROBLEM HAS BEEN ONGOING FOR A FEW MONTHS NOW. J & J IS CLEARLY NOT MONITORING THEIR QUALITY CONTROL ADEQUATELY. RPTR WRITES TO MFR: "ENCLOSED, PLEASE FIND 5 GLOVES AND A PORTION OF A BOX SHOWING THE EXACT MODEL. THESE WERE COLLECTED OVER ABOUT A 2 WEEK PERIOD, AND ARE EXACTLY AS TAKEN OUT OF THE BOX. YOU WILL NOTE THAT EACH HAS A SIGNIFICANT HOLE IN IT. THE MOST COMMON AREA IS A FINGER, WHERE THE LATEX DIDN'T FULLY FUSE, LEAVING A VOID. HOWEVER, THERE ARE ALSO HOLES AND APPARENT TEARS. ANOTHER AGGRAVATING EXPERIENCE IS TAKING OUT A GLOVE, ONLY TO FIND IT IS THE WRONG SIZE (SMALLER) THAN WHAT IS LABELED ON THE BOX. I DO NOT WORK IN A STERILE FIELD, AND A LITTLE SALIVA ON INTACT SKIN DOES NOT NORMALLY CREATE A PROBLEM. HOWEVER, PAYING THE PREMIUM PRICE CHARGED FOR J & J GLOVES DOES NOT SET WELL IN LIGHT OF WHAT IS APPARENTLY A SERIOUS LACK OF ANY SORT OF QUALITY CONTROL DURING MFR AND PACKAGING. THE PROBLEM WITH HOLES HAS GOTTEN WORSE IN THE LAST FEW MONTHS - IT DIDN'T SEEM TO BE A PROBLEM BEFORE THEN. DESPITE THE FACT THAT I LIKE THE FIT AND FEEL OF J & J GLOVES BETTER THAN ANY OTHERS I HAVE TRIED, I'M IN THE PROCESS OF SWITCHING BRANDS. J & J HAS ALWAYS ENJOYED AN EXCELLENT REPUTATION. I'M HOPING THAT STEPS CAN BE TAKEN TO RECTIFY THE CURRENT SITUATION, SO THAT YOUR FINE REPUTATION WILL NOT BE DAMAGED SERIOUSLY."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 J & J MEDICAL EXAM. GLOVES LYY JOHNSON & JOHNSON MEDICAL DIV. OF ETHICON, INC. * 104827-B

Patients

Seq Age Sex Outcome Treatment
1 *