MAUDE Adverse Event Report: ETHICON INC. SURGICEL ORIGINAL 4INX8IN(10.2CMX20.3CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 1952

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 07/21/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).H6.Component code: g07002 - device not returned 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.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 that a patient underwent a tracheotomy procedure on an unknown date and absorbable hemostat was used.The patient was left with a part of the absorbable hemostat exposed to the environment and apparently this generated contamination of the product and infection.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested, and the following was obtained: 1.What was the date of index surgical procedure? (b)(6) 2023.2.What were the diagnosis and indication for the index surgical procedure? open tracheostomy.3.Please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions): no all concomitant medications: none past medical history, any treatment required for events, dose, frequency, and therapy dates: the past history is related to mental health.Patient was in interrupted treatment with benzodiazepines.4.Was there any intraoperative concurrent use of other products? none 5.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? prophylactically 6.Where was the surgicel used (on what tissue)? was used into tracheal zone, and an extreme of product was exposed out of trachea 7.How was the surgicel placed? was it wadded up? yes was wadded up 8.How much surgicel was used during the procedure? was used 4in x 8in 9.What was the onset date of the infection? (b)(6) 2023.10.Were cultures performed? if yes, results? yes, cultures were performed.Acinetobacter baumannii and enterobacter aeruginosa 11.Has any surgical or medical intervention been performed? post infection, the tracheal tube was changed.12.What is physician¿s opinion as to the etiology of or contributing factors to this event? physician doesn¿t have any opinion about etiology.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.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h 4.Device manufacture date, h 6.Type of investigation.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: a3.Gender, b 2.Is required intervention, d4.Lot, d4.Expiration date, additional information was requested, and the following was obtained: 1.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? gender: female 2.What was the lot number? tab0501; exp: (b)(6) 2027 3.Please clarify what is meant by ¿exposed to the environment?¿ all product was used on procedure, but a part of the product was exposed 4.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative infection? in the review that was done with the hospital, they asked us for information on the use and absorption characteristics to understand why it was not given 5.What is the patient¿s current status? is receiving antibiotics to control the infection 6.What is the users experience w/ surgicel and other hemostatic agents? several years from residency 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.Corrected information: b2.Is other serious, h6.Health effect - impact code.

• Brand Name: SURGICEL ORIGINAL 4INX8IN(10.2CMX20.3CM)
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17497748
• MDR Text Key: 320773107
• Report Number: 2210968-2023-05766
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031003026
• UDI-Public: 10705031003026
• Combination Product (y/n): N
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/05/2023

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
• Device Catalogue Number: 1952
• Device Lot Number: TAB0501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 08/08/2023; 08/31/2023; 09/01/2023
• Supplement Dates FDA Received: 08/16/2023; 08/31/2023; 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2022
• 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): Other; Required Intervention
• Patient Sex: Female