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Model Number 66020626 |
Device Problem
Defective Component (2292)
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Patient Problem
Pain (1994)
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Event Date 08/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during wound treatment, the coban layer (4th layer) of a profore multi-layer compression latex free bandaging system was hard to unroll.It was possible to unroll about 3/4 of the bandage, but then it was extremely hard to it pull off.This caused the nurse and techs to hurt their shoulders for pulling so hard.Treatment was resumed, after a non-significant delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection reported no defects.The functional evaluation found the roll is difficult unroll, establishing a relationship between the device and the reported event.The root cause was identified as manufacturing process issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint history review has found other related events, with corrective action implemented related to the reported event.Smith + nephew will continue to monitor for adverse trends.
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Manufacturer Narrative
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H3, h6: 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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