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Model Number 66020626 |
Device Problems
Loss of or Failure to Bond (1068); Melted (1385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case (b)(4).
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Event Description
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It was reported that, the fourth layer of profore kit lff case 8, the coban layer, is fine when initialing wrapping the patient leg but then it gets down to the last 4th of the coban roll and becomes difficult to continue wrapping because the dressings is almost super glued/melted.Treatment was finished with a back up device, with less than 30 minutes of delay.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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The device, used in treatment, has been returned for evaluation.There was no obvious visual issue, however, the functional evaluation confirmed the profore layer 4 was difficult to unwind.A relationship against the reported event has been established.A complaint history review confirmed further instances of this nature.A review of the manufacturing records confirmed the device was released according to specification.A further review of the manufacturing process was also performed, and a root cause of inadequate standard operating procedure has been assigned.Corrective action has been assigned regarding this event to reduce the probability of further reoccurrences.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.
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Search Alerts/Recalls
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