The manufacturer received information alleging an amara mask caused a patient to have a cerebrospinal fluid leak due to the mask pushing on his nasal bone.The patient required surgery in response to the alleged event.The manufacturer has requested the return of the mask for evaluation, but the device has not yet been received.At this time, we are unable to confirm the allegation.A follow-up report will be submitted when the manufacturer's investigation is complete.
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The manufacturer previously reported receiving information alleging an amara mask caused a patient to have a cerebrospinal fluid leak due to the mask pushing on his nasal bone.The patient required surgery in response to the alleged event.The mask was returned to the manufacturer's quality product investigation lab for evaluation, and the customer's allegation was unable to be confirmed.An evaluation of the mask revealed signs of the mask being overtightened when in use, including excessive wear and stretching of the headgear that is associated with the device.This mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment.The mask is to be used on patients (>66lbs/30kg) for whom cpap or bi-level therapy has been prescribed.Product labeling warns users: "do not overtighten the headgear straps.Watch for signs of overtightening, such as excessive redness, sores or bulging skin around the edges of the mask.Loosen the headgear straps to alleviate symptoms." based on the information available, the manufacturer concludes no further action is required.
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