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Catalog Number MA1200-PM |
Device Problem
Excessive Heating (4030)
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Patient Problems
Burn(s) (1757); Skin Discoloration (2074)
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Event Date 12/28/2022 |
Event Type
Injury
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Event Description
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It was reported that this unit is thought to have possibly burned a patient during surgery.The blanket was applied waist down, patient laying on their left side for approximately 4hrs during surgery.It was noted that the patient developed very red skin but no blisters on the right thigh area.It was reported that, though the injury was categorized by caregivers as "moderate injury" but treatment was required (cold, wet cloth was immediately placed on the right thigh).No further information regarding treatment is available at this time.
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Manufacturer Narrative
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The patient treated the injury using cooling rags/towels and prescribed silvadene, which relieved the redness.The unit was set to high (43°c) and the skin was not periodically observed due to the procedure (laparoscopic hand assisted nephrectomy-kidney removal) being sterile.A cloth blanket and sterile drape were placed on top of the blanket during the procedure.A sr.Staff medical science liaison was consulted, who advised that weight from blankets or sterile drapes can cause additional pressure and/or potentially reduce air flow, which may have caused or contributed to the alleged event.The account requested to have the unit evaluated, and a visual and functional inspection was performed by a technical support specialist.It was identified that there was no defect identified with the unit.
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Event Description
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It was reported that this unit is thought to have possibly burned a patient during surgery.The blanket was applied waist down, patient laying on their left side for approximately 4hrs during surgery.It was noted that the patient developed very red skin but no blisters on the right thigh area.It was reported that the injury was categorized by caregivers as moderate injury on the right thigh.The patient treated the injury using cooling rags/towels and prescribed silvadene, which relieved the redness.
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Search Alerts/Recalls
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