The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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It was reported that while using dignishield for a burned icu patient, the device caused injury in the lower perianal area.The probe leaves the body with the cuff inflated, inflated it up to 60 cc.The probe leaked.Since it has no air escape, the bag inflates.The finger hook system was missing to install (flexiseal type).The material was rigid, and the probe was constantly clogged, which made it necessary to remove, wash and reposition continuously.
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