A review of the device history record was not completed as the lot number was unknown.All device history records are reviewed and approved by quality prior to release of product.Because there was no lot number, therefore a date of manufacture could not be determined.A sample was not received with this complaint therefore, it is not possible to confirm the reported condition.From a root cause analysis perspective, the cause of the skin irritation it is most likely attributed to skin preparation, skin condition or specific skin sensitivities.It can also be caused by repeated placement of the electrodes in the same position which can irritate the skin.Biocompatibility testing is performed in accordance with iso 10993-1 and gel was found to be non-cytotoxic, non-irritating and non-sensitizing.The results of the manufacturing facility investigation were unable to confirm an exact root cause associated with the manufacture of product which would have contributed to the reported condition.Since this complaint is unconfirmed, no complaint trend exists and a specific root cause for the occurrence cannot be identified, no corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.
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