[18448483]
The patient, an 80 year old female began use of the controlled cold therapy unit on 6/2/93, immediately following total kne surgery. Aprox. 36-48 hours post-op, at initial bandage change, a 2" square area of necrotic tissue was noted under hose connectors, not adjacent to area under cold therapy treatment. The hose were resting on a 4 x 4 pad. At the time of incident, the temperature read out was 50 degrees f, which was within normal operating specs. The patient was transferred out of the hospital and a skin graft was performed on 6/28/93. Md stated that patient had a history of hypersensitivity and allergies and felt that incident was not related to device. Ththisv incident was never reported to either the distributor or the manufacturer at the time of occurrence. The distributor's sales representative only coincidently became aware of the incident on 7/27/93 when making a sales call at the hospital to which the patient was transferred. Device labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5