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Catalog Number SP-101 |
Device Problem
Biocompatibility (2886)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 08/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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A patient was treated with a venaseal closure system in the great saphenous vein (gsv).The ifu was followed.Nothing unusual in the procedure.It was reported on the fifth day after surgery, redness was observed at the glue injection points (thigh, calf). for approximately 3 weeks after that, patient took 3 weeks of prescription of celestamine, but did not heal.The redness extends from the thigh to the perineum entirely.Symptoms of postoperative hypersensitivity was observed and treatment is ongoing until now, currently not resolved.
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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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Manufacturer Narrative
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Product analysis:four image files were returned for review: all for images show redness along the patients right thigh and calf consistent with the reported event.Additional information: when the redness appeared the drug was changed from celestamine to zyrtec, and the redness spread.Medication back to celestamine.The redness almost disappeared and there was no itching.Just in case, celestamine was prescribed for 2 weeks, but the patient did not take it and the follow-up was completed on (the patient did not come to the hospital).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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Event Description
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Additional information 01-nov-22: on (b)(6) 2022, the redness appeared, and on (b)(6) 2022, the drug was changed from celestamine to zyrtec, and the redness spread.On (b)(6) 2022, medication back to celestamine.On (b)(6) 2022, the redness almost disappeared and there was no itching.Just in case, celestamine was prescribed for 2 weeks, but the patient did not take it and the follow-up was completed on october 25 (the patient did not come to the hospital).
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Search Alerts/Recalls
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