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 Inflammation (1932)

Event Date 11/09/2021

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? event related to mw # 2210968-2023-08064, mw # 2210968-2023-08065.Citation: 10.1080/01676830.2021.2005633.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: nasal turbinate mucosal graft for management of contracted anophthalmic socket.Author(s): andrew w kam, christopher zq go, george he, david veivers & brett o¿donnell.Citation: 10.1080/01676830.2021.2005633.The aim of the study is to investigate the case of contracted socket and failed amniotic membrane grafting that subsequently underwent successful total socket reconstruction using a novel technique utilizing nasal turbinate mucosa grafts.A 67-year-old caucasian male presented with severe contraction of socket lining 8 years after enucleation, dermis fat graft and successful ocular prosthesis fitting.Following two failed attempts at using amniotic membrane grafts to reform the socket lining, a total socket reconstruction was attempted using a novel nasal turbinate mucosal graft technique.This was performed in a staged fashion with lower fornix reconstruction followed by upper fornix reconstruction 3 months later.During the procedure, surgicel (ethicon), 6-0 vicryl (ethicon) and 4-0 nylon suture (ethicon) were utilized as absorbable hemostat and in the closure of the incision.The reported complication included discharges (n=1) treatment: steroids, and inflammation (n=1) treatment: medication.In conclusion, the case of successful novel use of nasal turbinate mucosa as a total socket reconstruction material in a contracted anophthalmic socket where amniotic membrane and dermis fat graft had failed.Further orbit 325 studies of nasal turbinate mucosa are needed to determine its safety profile, longevity, and rate of complications.

• 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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17974991
• MDR Text Key: 326145160
• Report Number: 2210968-2023-08063
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/20/2023

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: 10/09/2023
• Initial Date FDA Received: 10/20/2023
• 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