MDR event

Additional Manufacturer Narrative

SINCE NO PRODUCT WAS RETURNED TO DATE, BATCH RECORDS WERE REVIEWED AND NO DEFECTS WERE NOTED. BASED ON REVIEW OF THE COMPLAINT DATA, THERE ARE NO OTHER COMPLAINTS OF THIS NATURE INVOLVING THIS PRODUCT. THE CONSUMER STATED PREVIOUS USE OF THE PRODUCT, HOWEVER, NO INDICATION OF WHETHER THIS IS THE FIRST TIME THE PRODUCT WAS USED DURING PREGNANCY. NO CONCLUSION CAN BE REACHED BASED ON THE AVAILABLE INFORMATION.