(b)(4).Investigation - evaluation: a review of complaint history, functional testing, drawings, instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: "clean area surrounding bartholin gland with appropriate antiseptic solution.¿ the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The root cause could be related to the patient's condition at the time of this occurrence.Prior biocompatibility testing ensures that the device is biocompatible and will not cause adverse effects within the patient during use.Based on the information provided, the root cause cannot be definitively determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment no further action is required.
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