MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Additional information was requested, and the following was obtained: please provide the following patient demographic information, if available: weight, bmi at the time of index procedure? a (b)(6) year-old woman.What is the date of index surgical procedure? no further information is available.What were the diagnosis and indication for the index surgical procedure? acute sphenoid sinusitis.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.The patient had no past history.What is the brand name of the fibrin sealant product used? no further information is available.What are the product code and lot number of the surgicel? the product code and the lot number is unknown.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? support for the tissue.Where was the surgicel used (on what tissue)? the left nasal septal mucosa was taken as a free graft, and the thinned area was applied with fibrin glue and covered with surgicel.What is physician¿s opinion as to the etiology of or contributing factors to this event? no further information is available.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative course? no further information is available.What is the patient¿s current status? no further information is available.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative patient consequences described in the article? no further information is available.No further information will be provided.The citation is oto-rhino-laryngology, tokyo.64(2)92-100.

Event Description

It was reported via a journal article: we report a case of acute sphenoid sinusitis with inflammation of the cavernous sinus.Case: the patient was a (b)(6) year-old woman.The patient had no past history.He was admitted to our hospital with severe headache and fever.Computed tomography and magnetic resonance imaging showed a soft tissue density shadow in the left sphenoid sinus.Inflammation of the acute sphenoid sinusitis was considered to have spread to the left cavernous sinus on imaging tests, and the patient was urgently admitted to the hospital, and administration of an antimicrobial drug (meropenem 2 g/day) was started.Endoscopic endonasal surgery was performed to drain the sphenoid sinus.The left nasal septal mucosa was taken as a free graft, and the thinned area was applied with fibrin glue and covered with surgicel.On the day after surgery, bacteremia was diagnosed, and the dose of meropenem was increased to 6 g/day.On day 7, ceftriaxone was de-escalated to 2 g/day, and the treatment was continued.On day 14, intravenous antibiotic therapy was terminated.The postoperative course was uneventful, and he was discharged on day 17.There has been no graft loss and no recurrence at 1 year.Conclusion: in patients with severe headache or oculomotor dysfunction, it is very important to make an early diagnosis by imaging examinations such as contrast-enhanced computed tomography (ct) and magnetic resonance imaging (mri), identify the causative organism, and administer appropriate antibiotics, as well as perform surgical drainage.It is recommended that the decision to initiate anticoagulation should be made in consultation with the neurology department.The patient was successfully treated with antibiotics and surgery without sequelae.Because no cranial nerve symptoms such as oculomotor disturbance occurred and no cranial nerve symptoms occurred after surgery, anticoagulation therapy was not performed.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 9/21/2021.Additional information received was the english translation of the journal article attached in mw#: 2210968-2021-07193.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.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12304815
• MDR Text Key: 267859655
• Report Number: 2210968-2021-07193
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR