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(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.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 provide the following patient demographic information, if available: age, weight, bmi at the time of index procedure? what is the date of index surgical 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 is the lot number? what was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? where was the surgicel used (on what tissue)? how much surgicel was used during the procedure? was the surgicel product left in place? was the excess irrigated and removed? what were current symptoms following the index surgical procedure? onset date? were cultures performed? if yes, 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 that contributed to the patient¿s post-operative infection and abscess? what is the patient¿s current status? 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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Product complaint # (b)(4).Date sent to the fda: 1/19/2021.Additional information was requested, and the following was obtained: 1.Please provide the following patient demographic information, if available: age, weight, bmi at the time of index procedure? 59 yo, female.2.What is the date of index surgical procedure? (b)(6)2020.3.What were the diagnosis and indication for the index surgical procedure? total hysterectomy.4.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.No further information is available.5.Was there any intraoperative concurrent use of other products? vicry suture 6.What is the lot number? qebczm.7.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? no further information is available.8.Where was the surgicel used (on what tissue)? the surgicel powder was used in the pelvis.9.How much surgicel was used during the procedure? no further information is available.10.Was the surgicel product left in place? was the excess irrigated and removed? physician commented that surgicel powder couldn't wash out completely at the first procedure.A laparotomy was performed again, and the surgicel powder was removed thoroughly.11.What were current symptoms following the index surgical procedure? onset date? the patient was underwent a suture surgery for vaginal site.12.Were cultures performed? if yes, results? no further information is available.13.What is physician¿s opinion as to the etiology of or contributing factors to this event? physician commented that originally the vagina was not clean and if they had washed up more, they would have avoided this issue.The physician also commented they couldn't decide if the cause of this issue was because of the products.14.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative infection and abscess? no further information is available.15.What is the patient¿s current status? the patient has been discharged from the hospital.And the progress is good.On (b)(6), the surgery was performed.During the surgery, bleeding occurred from the surface of the bladder where the uterus was separated.The surgicel powder was used to stop the bleeding.However, hemostasis could not be done successfully, then, some of surgicel powder fell onto the pouch of douglas.Before closing the abdominal cavity, cleaning was done with saline.(the surgeon commented that there is a possibility that excessive surgicel powder could not be cleaned up completely.) after the surgery, the body temperature did not go down, and it remained around 37.5 degrees celsius.2 days after the surgery, crp value suddenly increased to around 18.8.Administration of antibiotics was continued, but the condition was not improved, then, infection was suspected.On (b)(6), abscess was confirmed from the vagina.(gray drainage was observed.) on (b)(6), a second laparotomy was performed to remove the abscess.After removal of the abscess, the affected site was cleaned with a large amount of saline solution (10 l), then, the abdomen was closed.After the removal of the abscess, treatment was administration of antibiotics only.No other treatments were done.Then, the patient got recovered well.On (b)(6), the patient was discharged from the hospital.On (b)(6), the patient visited the hospital as the outpatient.Then, delayed healing on the vagina due to infection was observed.Since suturing had been done with vicryl, it was supposed that tensile strength of the suture was not enough, then, the sutured part became partially open.On (b)(6), vaginal suturing was performed at shiga university of medical science.[the patient¿s demographics] the patient was 59 years old.[treatment plan] follow up observation.[seriousness] not serious.[reason of the seriousness] infection and abscess.[the surgeon¿s comments] the abscess was cultured, then, it was found that enterococci were the source of infection.It was supposed that, enterococcus in the vagina was not cleaned up completely, then, it increased on the remained surgicell, causing infection.Then, it caused the abscess.There is a possibility that cleaning was not enough.If cleaning had been done completely, the issue might not have occurred.It is difficult to show the relationship between the surgicell powder and the issue.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Note: event related to surgicel reported via mw #2210968-2021-00415.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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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