Catalog Number 66802005 |
Device Problems
Loss of or Failure to Bond (1068); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2021 |
Event Type
malfunction
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Event Description
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It was reported that a new pico 7 kit was opened for application to a patient.After application, the machine was unable to seal, always leaking, thus maintaining the dressing without any negative pressure.Another machine from another kit was applied and started working right away.Customer informed that a large part of the silicone of the dressing was stuck to the film and not to the dressing, which may have caused the fact that the machine was unable to make the vacuum due to sealing.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Silicone offsetting may cause dressing cannot be tightly adhered on skin, which may result in the inability to make a vacuum, so potential factors that can contribute to the reported event include the wound contact layer raw material quality issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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Search Alerts/Recalls
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