ABDOMINAL BINDER
Received Oct 12, 2023 · Event occurred Sep 21, 2023
Report 3004605321-2023-00002 · MDR key 17923910
Device
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Unknown
- Rash
- Rash
Narrative
Additional Manufacturer Narrative
A COMPLAINT WAS RECEIVED ON 9/21/2023 REPORTING THE PATIENT DEVELOPED A RASH. PATIENT DISCONTINUED THE USE OF THE BINDER, BUT RASH DID SPREAD. THE PATIENT STATED THEY HAVE ALLERGIES TO CERTAIN PRODUCTS BUT DID NOT WANT TO SPECIFY. THE SAMPLE WAS NOT RETURNED TO DEROYAL FOR EVALUATION. DEROYAL WAS UNABLE TO DETERMINE THE TRUE ROOT CAUSE. DUE TO THE ROOT CAUSE FINDING THERE WERE NO CORRECTIVE AND OR PREVENTIVE ACTIONS TAKEN. 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 OF THE 13652067 BINDERS WERE 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
THE PATIENT DEVELOPED A RASH. PATIENT DISCONTINUED THE USE OF THE BINDER, BUT RASH DID SPREAD.
Additional Manufacturer Narrative
A COMPLAINT WAS RECEIVED ON (B)(6) 2023 REPORTING THE PATIENT DEVELOPED A RASH. PATIENT DISCONTINUED THE USE OF THE BINDER, BUT RASH DID SPREAD. THE PATIENT STATED THEY HAVE ALLERGIES TO CERTAIN PRODUCTS BUT DID NOT WANT TO SPECIFY. 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.