(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following operative report was obtained: date: 20-oct-2020, surgery: laparoscopic oophorectomy, intervention detail: findings: normal 360° vision.Healthy hollow viscera.Uterus in avf of normal shape.Healthy tubes.Right ovary with an 8 cm tumor with a smooth surface, without excresences.Healthy parietal and visceral peritoneum.Free anterior and posterior cul-de-sac.There is no free liquid.Technique: asepticization of the area.Gynecological lithotomy.Asepticization of the area.Pneumo with umbilical veress.Pelvic pressure.Suction is connected to a water trap with sodium hypochlorite.Complete tumor cystectomy.Selective hemostasis.Surgicell snow to the ovary.Suture to the ovary restored the anatomy.Extraction of parts by central access.Grooming and hemostasis.Trocar extraction under direct vision.Central access closure with vicryl.Monocryl to leather.Patient stable to recovery, gauzes count and compliant compresses.Conclusion: right ovarian cystectomy due to ovarian teratoma.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify which devices are involved in the hyperechoic mass found in the right ovary.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? what were the diagnosis and indication for the index surgical procedure? please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.Was there any intraoperative concurrent use of other products? what are the product code and lot number of the surgicel snow, stratafix suture, vicryl suture, monocryl suture? what was the intended use of the surgicel/surgiflo? was it used to address active bleeding or used prophylactically? where were the surgicel, surgiflo, stratafix, vicryl and monocryl sutures used (on what tissue)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how much surgicel was used during the procedure? was the surgicel product left in place? was surgiflo removed after hemostasis was achieved? what were current symptoms following the index surgical procedure? onset date? how long after the initial surgery was the mass discovered (the ultrasound)? has any surgical or medical intervention been performed? please include dates and results what is physician¿s opinion as to the etiology of or contributing factors to this event? was there an alleged deficiency of the surgicel, surgiflo, stratafix, vicryl or monocryl sutures that contributed to the patient¿s post-operative course? please specify.What is the patient¿s current status? are there pictures available that could be forwarded for review? related medwatch reports: 2210968-2022-04499.
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It was reported that a patient underwent a laparoscopic oophorectomy and cyst removal on (b)(6) 2020 and barbed suture was used on the right ovary.In a control ultrasound, a hyperechoic mass is found in the same right ovary, which is why a teratoma is suspected and the patient is operated on again.In surgery, the mass can be completely resected while preserving the annex.The anatomopathological study indicates the following: wall of fibrous connective tissue with little eosinophilic content of inorganic appearance and old hemorrhage in fibrous organization.In conversation with the doctor with this history, an adverse event associated with the first surgery was suspected.Additional information was requested.
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