ETHICON INC. SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
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Model Number 1961 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Unspecified Infection (1930); Pulmonary Edema (2020); Fluid Discharge (2686)
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Event Date 12/02/2021 |
Event Type
Death
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Manufacturer Narrative
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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.Additional information was requested, and the following was obtained: please provide the following patient demographic information, if available: weight and bmi at the time of index procedure? 28.7 bmi.What were the diagnosis and indication for the index surgical procedure? state post cholecystisis.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.Diapedeses, hypertension, c-section.It¿s stated that the surgeon believes the absorbable hemostat may have been surgicel.Please confirm that surgicel product code 1961 was used.It's most likely to be 1961.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? active bleeding.Where was the surgicel used (on what tissue)? above the tissue.How much surgicel was used during the procedure? 2 pieces 2.5*5.How was the surgicel placed? above the tissue.What is physician¿s opinion as to the etiology of or contributing factors to this event? bleeding, inflammation area, surgical (foreign body).What was the antibiotic therapy used to treat the patient¿s infection? invanz.The following information was requested, but unavailable: was there an alleged deficiency of the surgicel that may have cause or contributed to the patient¿s post-operative infection? was there an alleged deficiency of the surgicel that may have cause or contributed to the patient¿s post-operative death? event related to mw # 2210968-2022-00537.
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Event Description
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It was reported that a patient underwent a cholecystectomy procedure on (b)(6) 2021 and absorbable hemostat was used.An (b)(6) year old female patient with cholecystitis underwent cholecystectomy.The surgery was prolonged due to cholecystitis, severe adhesions and bleeding from the liver bed that couldn't be stopped with diathermia or tamponade.Hemostat treatment was used to stop the bleeding adjacent to the liver bed.The surgeon believes he used one or two units of 2.5x5cm.The lot number is unknown.According to the surgeon the use of the hemostat is not recorded in the surgery report as this is not the type of product he would normally record.On (b)(6), the patient was diagnosed with infection and re-hospitalized.The patient was treated with antibiotics and underwent a ct guided drainage procedure to drain the collection.On (b)(6), the patient was admitted to a second surgery carried out by a different surgeon during which the hemostat was removed and a leakage in the gallbladder was observed and was closed with a suture.No gallbladder collection was observed.The patient had cultures take both on (b)(6) came back with klebsiella pneumoniae.On (b)(6), the patient passed away.The reported cause of death was ards, - lungs edema not from the heart.According to the surgeon, the infection could have been caused by various contributors including: bile, reusable surgical instruments, etc.Additional information was requested.
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