FDA Adverse Event Injury Summary report: N

HUNTLEIGH FOOT GARMENT - SIZE UNKNOWN

MDR report key: 522900 · Received April 30, 2004

Report

Report Number
2431480-2004-00004
Event Type
Injury
Date Received
April 30, 2004
Report Date
April 30, 2004
Manufacturer
HUNTLEIGH HEALTHCARE, INC.
Product Code
JOW
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MI, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

A HOSPITAL CLINICIAN INFORMED HUNTLEIGH HEALTHCARE THAT SEVERAL POST-OP ORTHOPEDIC PATIENTS DEVELOPED SKIN BREAKDOWN OVER THE PAST YEAR WHILE USING THE FOOT COMPRESSION SYSTEM. IT WAS REPORTED BY THE CLINICIAN THAT ONE PATIENT DEVELOPED BILATERAL STAGE 4 PRESSURE ULCERS ON THE DORSAL FOOT AREA WHILE IN THE HOSP THAT REQUIRED DEBRIDEMENT FOLLOWING DISCHARGE AT ANOTHER HOSPITAL. ACCORDING TO THE HOSP CLINICAN, ONE PATIENT ALLEGEDLY DEVELOPED BILATERAL STAGE 4 PRESSURE ULCERS IN THE DORSAL AREA FOOT WHICH WERE TREATED WITH A TOPICAL OINTMENT DURING HOSPITALIZATION. THIS PATIENT SUBSEQUENTLY DISCHARGED, AND AFTER AN UNSPECIFIED PERIOD OF TIME POST-DISCHARGE, THE PATIENT SUPPOSEDLY REQUIRED SURGICAL DEBRIDEMENT PERFORMED AT ANOTHER HOSPITAL'S WOUND CARE CLINIC. NO ADDITIONAL MEDICAL INFORMATION WAS PROVIDED REGARDING THE PATIENT'S MEDICAL HISTORY, RISK FACTORS FOR SKIN BREAKDOWN, NUTRITIONAL STATUS, ETC. BY THE INITIAL HOSPITAL. UPON FURTHER INVESTIGATION, IT WAS LATER DETERMINED FROM THE WOUND CARE CLINIC THAT THIS PATIENT ACTUALLY HAD DEVELOPED STAGE 3 BILATERAL POSTERIOR HEEL PRESSURE ULCERS THAT REQUIRED DEBRIDEMENT AND ARE NOW RESOLVED. THE WOUND CARE CLINIC STAFF MEMBER STATED SHE DOES NOT BELIEVE THAT THE FOOT PUMP PRODUCT WAS THE CASUE OF THESE HEEL PRESSURE ULCERS AND STATED SHE SEES THESE TYPES OF HEEL PRESSURE ULCERS COMMONLY IN POSTOPERATIVE JOINT REPLACMENT PATIENTS. SHE ATTRIBUTES THE OOCURRENCE OF THESE HEELS PRESSURE ULCERS TO IMPROPER PADDING IN THE O.R. DURING SURGERY, INADEQUATE PRESSURE RELIEF OF HEELS WHILE IN BED, AND REDUCED MOBILITY POSTOPERATIVELY AS COMMONLY SEEN CAUSES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HUNTLEIGH FOOT GARMENT - SIZE UNKNOWN INTERMITENT FOOT COMPRESSION GARMENT JOW HUNTLEIGH HEALTHCARE, INC. UNK NA

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Required Intervention KENDAL ANTI-EMBOLIC STOCKINGS.| INTERVALS.| ACTIVE DORSIFLEXION OF EXTREMITY AT FREQUENT