SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 9.5X8.5CM CTN 20; TAPE AND BANDAGE, ADHESIVE
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Model Number 66000709 |
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 05/11/2021 |
Event Type
malfunction
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Event Description
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It was reported that, before the product was sent to a healthcare facility, was found the opsite post op 9.5x8.5cm ctn 20 had a foreign substance on the dressing.No case involved; therefore, no other complications were reported.
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Manufacturer Narrative
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The device intended to be used in treatment has been returned and evaluated, establishing a relationship with the reported event.The assessment confirmed that the thread-like foreign substance in the pad, with the root cause identified as pad raw material quality issue.The manufacturing record show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported events.This investigation is now complete with no further action deemed necessary.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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