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 Problems Foreign Body Reaction (1868); Granuloma (1876); Inflammation (1932); Discomfort (2330); Foreign Body In Patient (2687)

Event Date 10/06/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).H6.Component code: g07002 - device not returned.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.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.1.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number(s).2.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative patient consequences described in the article? 3.Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? 4.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.5.Can specific patient demographics: initials; age or date of birth; bmi; gender; 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 of study drugs be provided? citation: cureus 15(10): e46587.Doi 10.7759/cureus.46587.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.

Event Description

It was reported via a journal article: title: surgicel® granuloma mimicking recurrent thyroid tumor after thyroidectomy: a case report and literature review author: ehab alameer citation: cureus 15(10): e46587.Doi 10.7759/cureus.46587.In this case report, the author presents a case of a 42-year-old female patient who previously undergone a right thyroid lobectomy and isthmusectomy for follicular adenoma.The procedure and recovery were uneventful.Two years after the initial presentation, the patient returned with a visible anterior neck mass underlying the well-healed surgical scar, which was causing ¿disfigurement and a feeling of pressure in the neck.¿ ultrasound revealed that the right thyroid lobe had been surgically removed, but an elongated, well-defined isoechoic lesion measuring 2.5 × 1.5 × 0.8 cm was present in the operative bed.The lesion showed no calcifications.The left lobe was unremarkable.An fna of the lesion showed striated muscle fibers, a few macrophages, and degenerated debris, but no epithelial cells were identified.Upon reviewing the operative note from the initial surgery, it was confirmed that surgicel® was used for hemostasis at the conclusion of the surgery.Reported complications include surgicel® granuloma, which was causing ¿disfigurement and a feeling of pressure in the neck¿.The patient underwent surgical excision.In conclusion, surgicel® granuloma is a possible cause of recurrent thyroid-bed tumors.To accurately diagnose and manage this condition, a comprehensive medical history, imaging studies, and fna are crucial.This is particularly important in cancer patients, as a correct diagnosis can help avoid unnecessary aggressive interventions.

• 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
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18131540
• MDR Text Key: 328109606
• Report Number: 2210968-2023-08795
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2023

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: 11/09/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female