FDA Adverse Event Malfunction Summary report: N

LF ESMARK BANDAGE 3X12'

MDR report key: 20255738 · Received September 19, 2024

Report

Report Number
20255738
Event Type
Malfunction
Date Received
September 19, 2024
Date of Event
May 7, 2024
Report Date
June 4, 2024
Manufacturer
HARTMANN USA INC.
Product Code
GAX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MN
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

ON 5/7/2024 WE FILED A COMPLAINT WITH OUR DISTRIBUTION ABOUT THE DISCOLORATION OF THIS PRODUCT. WE HAD RECEIVED 2 CASES - THE PACKING THAT THE ESKMARKS WERE WRAPPED IN WERE ALL DISCOLORED. ON 5/14/2024 WE RECEIVED ANOTHER CASE OF THE 3 INCH ESMARKS ON OUR ORDER THAT HAD DISCOLORED PACKAGING. WE NOW HAD 3 CASES OF THESE. ON 5/14/2024 HARTMANN INDICATED THAT THE DISCOLORATION (YELLOWING) DOES NOT IMPACT THE PRODUCT QUALITY OR STERILITY. THEY INDICATED THAT THE REPORT WE SUBMITTED HAD BEEN DOCUMENTED AND REPORTED TO THE TEAM. AN INVESTIGATION DETERMINED THAT THERE WERE NO ABNORMALITIES FOUND DURING THE PRODUCTION PROCESS FOR THE REPORTED LOT. WE ALSO RECEIVED A LETTER FROM THE MANUFACTURER ADDRESSING THE DISCOLORATION AND SAYING THE PRODUCT IS SAFE TO USE. OUR CONCERN IS THAT IT¿S NOT JUST THE PACKAGING THAT IS DISCOLORED. THE PRODUCT INSIDE IS ALSO DISCOLORED AND IT IS HANDED OFF FOR USE IN THE STERILE FIELD. THEY HAVE AN EXPLANATION FOR THE DISCOLORATION, BUT HOW WOULD YOU KNOW IF IT¿S THAT OR WATER DAMAGE? IT WOULD BE DIFFICULT TO TELL THE DIFFERENCE. THE SEALS ON THE PACKAGING DO LOOK INTACT ¿ AT LEAST THE ONES WE HAVE HANDLED. THEY SAY IF YELLOWING IS NOTICED ON THE PACKAGE, WE SHOULD INSPECT SEALS TO BE CAUTIOUS BUT THEN SAYS THAT IT DOESN'T AFFECT THE EXPIRATION DATE OF THE PRODUCT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1449559 LF ESMARK BANDAGE 3X12' TOURNIQUET, NONPNEUMATIC GAX HARTMANN USA INC. X2305021 AND X2307025

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown