SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT; DRESSING, WOUND, OCCLUSIVE
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Model Number 66800269 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during treatment, a allevyn gentle border 7.5x7.5cm int had an insect between the foam layer and the top film.This happened before use in patient.Treatment was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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H10: the device, which was not used in treatment, has been returned and evaluated, establishing a relationship between the device and the reported event.Visual inspection confirmed an insect between the pink film and the pad.A failed in-process inspection has been identified as the root cause.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file does not contain further instances of the reported event.Operators were made aware of this complaint and re-trained to the in-process inspection work instruction.Smith and 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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