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Device Problem
Biocompatibility (2886)
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Patient Problems
Dyspnea (1816); Erythema (1840); Itching Sensation (1943); Rash (2033); Local Reaction (2035)
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Event Date 11/02/2022 |
Event Type
Injury
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Event Description
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A patient was treated with venaseal on (b)(6) 2022.On (b)(6) 2022 the patient experienced intense redness on thighs and lower leg to ankle.The physician prescribed a medrol pack, 800 ibuprofen and 25mg benadryl every six hours.On day 8, the patient work with a systemic rash on the neck, chest, stomach, both legs and the right ankle was swollen.Patients breathing was labored.The patient arrived to the emergency room and the patient was given an iv, zyrtec and 3cc's of pepcid.The redness and itchiness lessened.Patient was given a couple cc's of epi and remained in the emergency room for observation.The physician recommended a second medrol dose pack and to maintain 1 x zyrtec + 1 pepcid twice daily.Patient was symptom free for 5 days. the day the patient finished the medrol pack the redness reappeared on the right ankle and left inner knee/thigh.The patient used a steroid cream and ice pack to calm the redness.Patient is now symptom free.Patient is remaining on the 1 x zyrtec + 1 pepcid for 60 days in order to allow the wound to heal and for capsulation and scarring to occur around the glue.
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Manufacturer Narrative
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Medwatch# mw5113303.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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