[16356292]
Thigh hi ted were placed on patient postop on 1/29/92. On 1/31/92 at 0600, patient complained of pain in ankle radiating down to right foot. No pressure areas were noted. On 1/31/92 at 1500, redness was noted on right heel. Heel protectors applied. On 2/1/92 at 0700, patient's right foot was noted with multiple reddened areas on bony prominence and a dark purple area on bottom of heel (2-3 cm in size). Duoderm applied to area. Size of stockings were rechecked and proper size was applied originally. A previous incident had occurred to a 76 year old female in past week. Further evaluation involved surveying nurse managers if any problems had been detected with use of ted. On a couple occasions reports indicated that patients' dorsal area of foot were noted to be slightly redden at times and required ongoing inspection of feet and stimulation of circulation. Finally, two employees wore one thigh hi hose from medline and another thigh hi hose from another manufacturer to note for comparisons. The medline was a tighter fit especially behind knee and across foot. One employee experienced some redness above the knee area. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was multiple patient involvement. Number of patients involved: 2. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated, performance tests performed. Results of evaluation: design. Conclusion: other. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5