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Model Number IMPL DELIVERY SYS,DISTAL BICEPS REPR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Rash (2033)
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Event Date 07/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported by the patient that he had a distal bicep repair done in late (b)(6) 2020 and has had a body rash since that time.Additional information obtained 12/18/2020: the patient's implant surgery was(b)(6) 2020.His symptoms first appeared (b)(6) 2020.Symptoms has been a rash covering his body.To date the symptoms have been treated with creams, antihistamines, and phototherapy.No cultures have been taken to date.Patient also states that as of this date his surgeon, er doctor, allergist and one dermatologist all agree that the rash has nothing to do with his implant.His last dermatologist also thinks that it is not being caused by the implant.That dermatologist suggested researching the components to see if patient is possibly allergic to anything in the implant.The dermatologist is convinced also that whatever the patient is experiencing has nothing to do with the implants.Material composition has been provided to the patient.
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Search Alerts/Recalls
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