SMITH & NEPHEW MEDICAL LTD. MELOLIN NON STERILE ROLL 50CMX7M CTN 1; TAPE AND BANDAGE, ADHESIVE
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Catalog Number 66974930 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during set up, it was noticed that the melolin non sterile roll had a few hair-like foreign substances.Procedure was completed, without any delay, using a back-up device.There was no patient involvement.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation.Without verifying the reported contamination and or batch/lot number the complaint cannot be confirmed.In addition the manufacturing records cannot be reviewed.Complaint history records shows previous cases of a similar nature.Following process reviews, manufacturing quality concerns have been identified.Corrective action has been implemented to reduce the probability of future occurrences.Product risk files adequality mitigate the reported event type, with no updates required.Potential causes include manufacturing missed quality checks.No additional actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.
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Search Alerts/Recalls
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