It was reported that in opsite flexifix 10cm x 10cm, ctn 1, a decoloration in the protective backing was found, also the tape appears more flimsy and edges curl causing lifting and in both occasions leaking of urostomy.There was no changes in urostomy output, the procedure was successfully completed using the same device.No patient injury, delay or other complications were reported.
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We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains further instances/ related events of the reported event.The device was used for treatment.The returned sample was evaluated.No issues were identified.The returned samples appeared to be within specification and adhered to skin satisfactorily.The reported issue may be attributed to application or maintenance techniques.We have not been able to confirm a relationship between the event and the device.The investigation has been closed as no device problem found.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.
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