KENDALL
Received Jun 26, 2026 · Event occurred Jun 7, 2026
Report 1423537-2026-00209 · MDR key 25640852
Device
Generic name
Sleeve, Limb, Compressible
Manufacturer
Cardinal Health 200, LlcModel number
84022Catalog number
84022
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Pressure Sore/Ulcer
- Blister
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED A PATIENT WITH A PAST MEDICAL HISTORY PERTINENT FOR TYPE I DM, DIABETIC NEUROPATHY, ESRD ON HEMODIALYSIS, AND CHRONIC RIGHT NON-HEALING FOOT WOUND WAS PLACED IN CARDINAL HEALTH KENDALL SEQUENTIAL COMPRESSION COMFORT SLEEVES PER ORDER ON (B)(6). DURING EVENING SKIN ASSESSMENT ON (B)(6), SCDS WERE REMOVED AND PRESSURE ULCERS WERE FOUND BENEATH LEFT SIDE, CAUSING BLISTERING ON THE PATIENT'S SHIN. SCDS WERE THEN REMOVED AND WOUND WAS CHARTED/PHOTOGRAPHED IN LDAW. PER ADDITIONAL INFORMATION AND PHOTOS PROVIDED BY THE REPORTER ON JUNE 23, 2026, AS OF ON (B)(6), ECCHYMOSIS WAS NOTED TO THE LEFT LOWER EXTREMITY. NO OPEN WOUND AT THE TIME. AS OF ON (B)(6) 2026, THE PRESSURE INJURY STAGE WAS CLASSIFIED AS DTPI. PERIWOUND: PINK AND RED. WOUND BED: RED AND PURPLE. NO WOUND UNDERMINING, TUNNELING, DRAINAGE OR ODOR WERE PRESENT. AS OF ON (B)(6) 2026, THERE WAS A SMALL AMOUNT OF SEROUS DRAINAGE WITH ODOR ABSENT, WITHOUT PERIWOUND ERTHYMA, CREPITUS, NECROSIS, OR GANGRENE. DEBRIDEMENT TYPE: MECHANICAL. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE FACILITY.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.