The lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a bite blox was used during an esophagogastroduodenoscopy procedure performed on (b)(6) 2019.According to the complainant, a day after the procedure, the patient had an allergic reaction to the bite blox.Reportedly, the patient was having fever and had blisters and sores around the mouth area.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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