BACK SUPPORT, SOLACE, L

Additional Manufacturer Narrative

A VOLUNTARY MEDWATCH REPORT (#MW5113275) WAS RECEIVED ON 11/23/2022 REPORTING AN ORTHOPEDIC DOCTOR ORDERED A DEROYAL BACK BRACE FOR THE END USER. THE FIRST DAY THEY WORE IT, THE EDGES OF THE VELCRO SLICED THEIR ARM OPEN TWICE. BOTH INJURIES BLED ENOUGH THAT THEY HAD TO PUT PRESSURE AND BANDAGE THEM. THE ENDS ARE HARD AND SHARP, AND THE END USER WILL NOT BE ABLE TO CONTINUE USING THIS BRACE. AN INVENTORY CHECK WAS MADE BY DEROYAL OF PRODUCT ON HAND, A TOTAL OF 3 OF THE 13400007 SOLACE BACK SUPPORT LOT NUMBER 54423480 WERE INSPECTED. THERE WERE DISCREPANCIES IDENTIFIED DURING THIS INSPECTION. THE SIDE PULLS WERE PLACED ON THE OPPOSITE SIDES CAUSING THE ROUGH EDGE OF THE WEBBING TO BE AT THE TOP OF THE POCKET, NOT ON THE BOTTOM. THE SAMPLE WAS NOT RETURNED TO DEROYAL FOR EVALUATION. THE MEDWATCH REPORT STATES THE DEVICE IS AVAILABLE FOR EVALUATION BUT THERE WAS NO CONTACT INFORMATION PROVIDED. A SPECIFIC LOT NUMBER WAS NOT PROVIDED BY THE END USER. IF THE COMPLAINT PRODUCT WAS FROM THE SAME LOT NUMBER IDENTIFIED BY THE INVENTORY CHECK THE ROOT CAUSE WAS DETERMINED TO BE AN ASSEMBLY ERROR DURING INSPECTION. THE SIDE PULLS WERE PLACED ON THE OPPOSITE SIDES CAUSING THE ROUGH EDGE OF THE WEBBING TO BE AT THE TOP OF THE POCKET, NOT ON THE BOTTOM. THE FOLLOWING CORRECTIVE ACTIONS HAVE TAKEN PLACE BY DEROYAL: THE 3 EACH FOUND DURING THE INVENTORY CHECK THAT WAS ASSEMBLED INCORRECTLY WERE REWORKED INTO LOT NUMBER 58370354. THE INSPECTOR WAS RE-TRAINED ON THE TASK OF ASSEMBLING THE SOLACE BACK SUPPORTS, SPECIFICALLY FOR PRODUCTS HAVING ROUGH EDGES. COMPLAINTS WILL BE MONITORED FOR THESE TYPES OF ISSUES. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR THE 13400007 SOLACE BACK SUPPORT. 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

MY ORTHOPEDIC DOCTOR ORDERED A DEROYAL BACK BRACE FOR ME. THE FIRST DAY I WORE IT, THE EDGES OF THE VELCRO SLICED MY ARM OPEN TWICE. BOTH INJURIES BLED ENOUGH THAT I HAD TO PUT PRESSURE AND BANDAGE THEM. THE ENDS ARE HARD AND SHARP, AND I WILL NOT BE ABLE TO CONTINUE USING THIS BRACE.