Model Number DGP-PMC-10 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Burn(s) (1757)
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Event Date 05/04/2019 |
Event Type
Injury
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Event Description
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A report was received that the patient experienced a grounding pad burn on the leg due to an abundance of unshaven leg hair which caused a gap between the grounding pad and leg.The physician assessed that the wound was a second degree burn.The patient was referred to the wound care clinic, however, he refused treatment.Upon follow up, the physician assessed that the patient is doing well.
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Manufacturer Narrative
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The returned grounding pad was analyzed and the allegation of a grounding pad burn was confirmed.Visual inspection revealed that the grounding pad had hair stuck on it in several areas.The labeling review was performed and from the information available, this device was not used per the directions for use.Pictures displayed the leg was completely unshaven which resulted in the electrosurgical burn.The grounding pad was improperly placed onto the patients leg which is the cause of the burn.The probable cause selected is failure to follow instructions.
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Event Description
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A report was received that the patient experienced a grounding pad burn on the leg due to an abundance of unshaven leg hair which caused a gap between the grounding pad and leg.The physician assessed that the wound was a second degree burn.The patient was referred to the wound care clinic, however, he refused treatment.Upon follow up, the physician assessed that the patient is doing well.
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Search Alerts/Recalls
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