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Model Number TMP2008G |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Pain (1994); Swelling/ Edema (4577)
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Event Date 03/10/2021 |
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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According to the reporter, post-operatively, the patient returned to the hospital due to great pain and a puncture took been carried out.The patient had also been prescribed dafalgan and pyostacine.The surgeon also confirmed that the patient has indeed an abscess.This may require removal of the prosthesis.
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Event Description
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According to the reporter, seven days after an ileocecal resection by laparoscopy, the patient returned to the hospital due to great pain and drained the hematoma by puncture.The patient had subcutaneous umbilical swelling.The surgeon also confirmed that the patient has indeed an abscess.The patient was prescribed with antibiotics (darfalganand ptostacine, metronidazole, ciprofloxacin).This may require removal of the prosthesis.It was noted that at the end of surgery, the surgeon did a midline incision to take out anatomic piece in order to send it at anapathologic laboratory.
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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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