Without a lot number the device history records review could not be completed.Product was not returned.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
It was reported that on (b)(6) 2019, the patient had spinal fusion surgery.Immediately after the surgery the patient felt good, but one week after, the patient was at the emergency room with an allergic reaction.He was given benadryl and symptoms improved.His condition has deteriorated and in pain every day.He had a prior surgery in the 1990s where stainless steel or titanium rods and screws were implanted in his hand and had to be removed because of allergic reaction that caused the surgery site not to heal.Upon removal of the implants, the hand healed.The current surgeon was notified of the issue with the prior surgery but insisted that materials had changed since the 1990s and the possibility of an adverse reaction were minuscule.Because of the patient urged the surgeon to get him allergy tested because of how he feels, he did put in an order and was tested, however, upon completion of the testing he was told he was tested for the wrong items.The patient have not heard back from anyone and now taking his healthcare into his own hands and would like to have independent allergy testing performed.The patient needs information from the company in order to do so.This is report 7 of 10 for (b)(4).This (b)(4) capture the 10 out of 12 devices reported/received and (b)(4) capture the other 2 out of 12 devices reported/received.
|