SMITH & NEPHEW MEDICAL LTD. MELOLIN NON STERILE ROLL 50CMX7M CTN 1; DRESSING,WOUND,OCCLUSIVE
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Catalog Number 66974930 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2020 |
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, when the brand-new melolin roll was taken out of the package, it was confirmed there were stains on the dressing, so it was not used for treatment.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was received for evaluation.At the present time we are unable to locate the sample ,with steps taken to prevent a re-occurrence.We have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include a manufacturing process issue.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported events.This investigation is now complete with no further action deemed necessary.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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