MEDI-TECH

Additional Manufacturer Narrative

DEVICE NOT RETURNED FOR ADDITIONAL INVESTIGATION. NO EVIDENCE THE DEVICE MALFUNCTIONED, INSTRUCTIONS AND NEW PACKAGING REVIEWED WITH USER.

Description of Event or Problem

ON 6/4 MARKETLAB BECAME AWARE OF A REPORT FROM THE (B)(6)ALLEGING SAG35036 (SPANDAGRIP PRE-CUT NATURAL 2.75" X 36") CONTRIBUTED TO A PATIENT INJURY DESCRIBED BY THE REPORTER AS A "SIGNIFICANT PRESSURE INJURY". THE REPORTER STATES THAT AROUND (B)(6) 2024 (REPORTER IS UNSURE OF EXACT DATE), SAG35036 WAS USED ON THE PATIENT. THE PATIENT WAS BEING TREATED FOR EDEMA AND CELLULITIS WHEN A CLINICIAN APPLIED SPANDAGRIP. THE REPORTER STATED: "STOCKINGS WERE PLACED ON LEG WITHOUT CUTTING OFF EXCESS TO FIT LENGTH OF LEG". REPORTER FURTHER STATED THAT AROUND (B)(6) 2024 (REPORTER IS UNSURE OF THE EXACT DATE) THE SPANDAGRIP WAS REMOVED BY A CLINICIAN. THE REPORTER FURTHER STATES THAT ON (B)(6) THE SPANDAGRIP WAS NOT PRESENT ON THE PATIENT WHEN AN ASSESSMENT TOOK PLACE. THIS IS WHEN THE "SIGNIFICANT PRESSURE INJURY" WAS NOTED BY THE REPORTER. ON (B)(6) THE REPORTER STATED THE PATIENT HAS AN UNSTAGEABLE PRESSURE INJURY. REPORTER ALSO STATED "PATIENT REMAINS AS AN INPATIENT AND WILL BE GOING TO THE O.R. TOMORROW FOR DEBRIDEMENT". REPORTER ALSO ADDED THE "OUTSIDE PACKAGING HAS CHANGED FOR PRODUCT. NOT SURE IF THIS IMPACTED THIS PARTICULAR PATIENT. SIZING IS VERY DIFFICULT TO DETERMINE ON NEW PACKAGING."