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ETHICON INC. SFX SPI PDS+ UNI VIO 12IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
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| Model Number SXPP1B416 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Failure to Anastomose (1028); Adult Respiratory Distress Syndrome (1696); Nausea (1970); Pain (1994); Vomiting (2144)
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| Event Date 07/01/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.(b)(4).This report is related to a clinical trial, therefore no product will be returned for analysis.Additional information was requested, and the following was obtained: what is the lot number? - qcbazr.Were prescription steroids or antibiotics administered for patient's recovery? - pt on iperacillin/tazobactam (start: (b)(6) 2021 3.365g 50ml intravenous (infuse over 4 hours) and administered 3x daily.) mometasone/formoterol 200 ug/5ug inhaler 2 puffs x2 a day) what is the current status of the patient? - pt is still inpatient recovering well device return status: - during the repair procedure the same sutures were used so i would say the device was not removed.Additionally, i do not see in the op note that it was removed.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength = 2360 g/m.
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Event Description
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It was reported during clinical trial that the patient underwent a bariatric sleeve gastrectomy on (b)(6) 2021 and the barbed suture was used for reinforcement of the staple line.On (b)(6) 2021, the patient experienced sob and stomach pain and was admitted resulted without medical or surgical intervention.Diagnostic imaging observation was done.Outcome recovered/resolved on (b)(6) 2021.It was reported that the chest pain was possibly related to the procedure and not related to the device.On (b)(6) 2021 the patient was hospitalized for perforated gastric sleeve.During repair procedure, the same sutures were used, the initial barbed suture was not removed.The iperacillin/tazobactam 3.365g 50ml intravenous infusion over 4 hours as 3 times daily started on (b)(6) 2021.In addition, mometasone/formoterol 200 ug/5ug inhaler 2 puffs twice a day was given.The patient is still in the hospital and recovering well.It was reported that the leakage was possibly related to the procedure and possibly related to the device.Additional information will be requested.
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Manufacturer Narrative
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Date sent to the fda: 09/04/2021.Additional h 6.Health effect - clinical codes: e1032.Additional information/updated log line information was provided: 1.Update for perforated gastric sleeve: post-op complication perforated gastric sleeve was recovered/resolved and the patient was discharged.Discharge date on (b)(6) 2021; did this event result in the subject's discontinuation of the study? if yes, complete the study discontinuation form.No; outcome / recovered/resolved.2.New outcome: dark colored vomitus, started on (b)(6) 2021 ( hospitalization) end date: on (b)(6) 2021; diagnostic imaging: yes; non-surgical therapy or intervention: yes; did this event result in the subject's discontinuation of the study? no ; relationship to study device not related; relationship to primary study procedure: is the adverse event serious? yes; severity mild required in-patient hospitalization or prolongation of existing hospitalization yes; adverse event term hospitalization - dark colored vomitus; outcome -recovered/resolved.Attempts are being made to clarify 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.1.It states that relationship to primary study procedure: please clarify relationship of dark colored vomitus started on (b)(6) 2021 and ended on (b)(6) 2021 to primary study procedure? 2.Please specify a non-surgical therapy/intervention for dark colored vomitus outcome? 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.
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Manufacturer Narrative
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Date sent to the fda: 08/12/2021.A manufacturing record evaluation was performed for the finished device batch: qcbazr, sxpp1b416 and no non-conformances were identified.Additional information was requested, and the following was obtained: 1.The patient weight, bmi at the time of index procedure and other relevant patient history/concomitant medications.Patient demographics: height 69 in ; weight 353 lb.Med hx: morbid history, astma, anxiety, migraines, environmental/seasonal allergies, dvt, infertility/pocs (polycystic syndrome); surg hx: myringotomy tubes, tonsillectomy and adenoidectomy, right hand orif, d&c.2.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during re-operation: the surgeon was very satisfied with the device (needle penetration, needle -suture strength, the needle suture size, suture handling), no any deficiencies observed.3.Update for chest pain: injected medication (if applicable, complete concomitant medications form) no - yes site awareness date 06 jul 2021 - 02 jul 2021.4.Update for perforated gastric sleeve: if the event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? blank, no.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.
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Manufacturer Narrative
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Product complaint #
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> (b)(4).Date sent to the fda: 09/29/2021 additional h6.Health effect- clinical codes: e1020 additional information/updated log line information was provided: update log line 3: name of adverse event: dark colored vomitus updated: relationship to primary study procedure: unlikely admission date: 11 aug 2021 discharge date: 13 aug 2021 resulted in medical or surgical intervention: no.Update log line 4: adverse event term: nausea start date: (b)(6) 2021; end date: (b)(6) 2021 type of procedure: sleeve gastrectomy; date of procedure: 30 jun 2021 severity: mild is the adverse event serious? no required in-patient hospitalization or prolongation of existing hospitalization: no; resulted in medical or surgical intervention: no; relationship to study device: not related relationship to primary study procedure: unlikely injected medication: yes outcome: recovered/resolved did this event result in the patient's discontinuation of the study? no 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.
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Manufacturer Narrative
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Product complaint # (b)(4).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.Additional information/updated log line information was provided: update log line 2: adverse event term: perforated gastric sleeve.Updated: injected medication: yes.Start date: (b)(6) 2021.End date: (b)(6) 2021.Relationship to study device: possible relationship to primary study procedure: possible.Diagnostic intervention: yes.Aspiration/drainage: yes.Injected medication: yes.Diagnostic imaging: yes.Does this adverse event meet the definition of a uade? yes.Outcome: recovered/resolved.Updated log line 5.Start date: (b)(6) 2021.Adverse event term: dark colored vomitus.End date: (b)(6) 2021.Severity: mild.Is the adverse event serious? no.Required in-patient hospitalization or prolongation of existing hospitalization: no.Relationship to study device: not related relationship to primary study procedure: not related.Oral medication: yes.Diagnostic imaging: no.Outcome: recovered/resolved.
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Manufacturer Narrative
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(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.The following additional information was received: updated log line 7.Intervention/treatment.(check 'none' or all that apply)none -> no - yes oral medication (if applicable, complete concomitant medications form) -> yes - no.
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Manufacturer Narrative
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(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.Additional information was requested, and the following was obtained: updated log line 5.Oral medication.Yes - no.Updated log line 5.Intervention/treatment.None.No - yes.
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