ABDOMINAL BINDER

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED ON 9/15/2023 REPORTING PATIENT COMPLAINED OF A RASH LOCATED WHERE THE ABDOMINAL BINDER WAS LOCATED. FOR THIS PATIENT, USE OF THE ABDOMINAL BINDER WAS IMMEDIATELY DISCONTINUED, RESULTING IN THE RASH RESOLVING SHORTLY. THE ACTUAL SAMPLE WAS NOT RETURNED TO DEROYAL FOR EVALUATION. THEREFORE, A TRUE ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 WORK IN PROCESS CHECKS AND AN INVENTORY CHECK OF THE ABDOMINAL BINDER WAS MADE BY DEROYAL, A TOTAL OF 50 EACH OF THE 13662067 WERE INSPECTED, AND NO DISCREPANCIES WERE IDENTIFIED DURING EACH INSPECTION. BETWEEN JULY 1, 2021 - OCTOBER 16, 2023, THERE HAVE BEEN A TOTAL OF FIVE COMPLAINTS REPORTED FOR THIS ABDOMINAL BINDER. ONLY TWO WERE RELATED TO RASH AND (B)(6) UNITS SOLD FOR A PERCENTAGE OF 0.003%. 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.

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED ON (B)(6) 2023 REPORTING PATIENT COMPLAINED OF A RASH LOCATED WHERE THE ABDOMINAL BINDER WAS LOCATED. FOR THIS PATIENT, USE OF THE ABDOMINAL BINDER WAS IMMEDIATELY DISCONTINUED, RESULTING IN THE RASH RESOLVING SHORTLY. THIS INVESTIGATION IS ONGOING 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

PATIENT COMPLAINED OF A RASH LOCATED WHERE THE ABDOMINAL BINDER WAS LOCATED. FOR THIS PATIENT, USE OF THE ABDOMINAL BINDER WAS IMMEDIATELY DISCONTINUED, RESULTING IN THE RASH RESOLVING SHORTLY.