BNDG,TUBLR,MEDIGRIP SZ G 4-3/4W,LF

Additional Manufacturer Narrative

UPDATE TO H10 AS REQUESTED- HEALTHCANADA REPORT NUMBER ADDED AS A "RELATED REPORT NUMBERS".

Description of Event or Problem

ACCORDING TO THE REPORT, ON 01/02/2025 "THE PRODUCT DESIGN DOES NOT CONFORM PROPERLY TO THE FULL LENGTH OF THE LEG, RESULTING IN BUNCHING AT THE ANKLE AND A LOOSE FIT AROUND THE FOOT", AND "AS A RESULT OF IMPROPER FIT AND DIFFICULTY IN USE, THE CLIENT SUSTAINED SKIN INJURIES THAT REQUIRED ADDITIONAL MEDICAL TREATMENT".

Additional Manufacturer Narrative

ACCORDING TO THE REPORT, ON 01/02/2025 "THE PRODUCT DESIGN DOES NOT CONFORM PROPERLY TO THE FULL LENGTH OF THE LEG, RESULTING IN BUNCHING AT THE ANKLE AND A LOOSE FIT AROUND THE FOOT", AND "AS A RESULT OF IMPROPER FIT AND DIFFICULTY IN USE, THE CLIENT SUSTAINED SKIN INJURIES THAT REQUIRED ADDITIONAL MEDICAL TREATMENT". THE REPORT DOCUMENTED THAT THE PATIENT REQUIRED "ADDITIONAL WOUND CARE TO MANAGE THE RESULTING SKIN DAMAGE". THE REPORT DID NOT DOCUMENT ANY SERIOUS INJURY RELATED TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.