ABDOMINAL BINDER

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED ON 11/15/2023 REPORTING SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION. A REPRESENTATIVE SAMPLE OF THE PRODUCT WAS RETURNED TO DEROYAL FOR EVALUATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE RAW MATERIAL SUPPLIER NORTH EAST KNITTING. THE SUPPLIER STATED ALL INTERNAL REQUIRED PROCESS CONTROLS WERE FOLLOWED. THERE HAVE BEEN NO CHANGES IN THEIR MANUFACTURING PROCESS AND OR RAW MATERIALS. DEROYAL WAS UNABLE TO DETERMINE THE TRUE ROOT CAUSE. DUE TO THE ROOT CAUSE FINDING THERE WERE NO CORRECTIVE AND OR PREVENTIVE ACTIONS TAKEN. THERE HAVE BEEN NO CHANGES MADE TO THE RAW MATERIAL USED FOR THIS ABDOMINAL BINDER. PRODUCT LABELING WAS REVIEWED, AND NO ISSUES RELATED TO LATEX WERE FOUND. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. A TOTAL OF 50 SAMPLES WERE RANDOMLY INSPECTED BY DEROYAL, AND NO DISCREPANCIES WERE IDENTIFIED DURING EACH INSPECTION. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

SEVERAL FEMALE PATIENTS BROKE OUT IN A RASH ACROSS THE AREA WHERE THE BINDER WAS ON THEIR SKIN. USED IN LABOR AND DELIVERY POST C SECTION.