THERAPEARL BACK WRAP WITH STRAP

Additional Manufacturer Narrative

MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO ANOMALIES FOUND. A REVIEW OF PAST COMPLAINTS WAS PERFORMED FROM (B)(6) 2018 REGARDING DEFECTS IN THE THERA PEARL BACK WRAP WITH KNOWN LOT AND THIS WAS THE ONLY COMPLAINT RECEIVED. THE BACK PACK WAS RETURNED TO THE HYGENIC CORPORATION FOR EVALUATION AND THE RETURNED PACK DID NOT HAVE ANY DEFECTS (I.E. TEARS, ABRASIONS, HOLES) THAT COULD HAVE RESULTED IN INJURY. THE PACK WAS TESTED WITH A 1000W MICROWAVE AT 55S (PER PACK INSTRUCTIONS). AND THEN AGAIN AT 1MIN IN THE 1200W MICROWAVE (AS A WORST CASE BASED ON THE CUSTOMER'S STATEMENT). THERAPEUTIC RANGE IS CONSIDERED TO BE 37-51C. THE BACK PACK TEMPERATURE NEVER EXCEEDED THIS RANGE. THE PACK WAS ALSO WEIGHED AND FOUND TO BE SLIGHTLY UNDERWEIGHT (2G), BUT AS SHOWN BY THE KINETIC DATA THIS DID NOT AFFECT THE PACK'S HEATING PROFILE.

Description of Event or Problem

ON (B)(6) 2019 THE HYGENIC CORPORATION RECEIVED NOTIFICATION OF AN ADVERSE EVENT INVOLVING THE THERAPEARL FRENCH GERMAN DUTCH DOS BACK WRAP WITH STRAP REUSABLE HOT/COLD BACK PACK. THE FEMALE USER REPORTED MICROWAVING THE DEVICE FOR ONE MINUTE PRIOR TO A 15 MINUTE APPLICATION TO HER BACK. SHE REPORTS DEVELOPING TWO BLISTERS AFTER APPLICATION. THE USER CONSULTED A PHARMACIST WHO REPORTED THE EVENT TO THE DISTRIBUTOR, ON (B)(6) 2019. THE REPORT IDENTIFIES THE INJURY AS A SECOND DEGREE BURN, HOWEVER FURTHER DETAILS OF TREATMENT OR PATIENT CONDITION COULD NOT BE OBTAINED WITH FOLLOW UP TO THE USER.