MAUDE Adverse Event Report: ETHICON INC. SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 1961

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Impaired Healing (2378)

Event Date 01/18/2024

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.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.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? 2.What were the diagnosis and indication for the index surgical procedure? 3.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.4.Was there any intraoperative concurrent use of other products? 5.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? 6.Where was the surgicel used (on what tissue)? 7.How much surgicel was used during the procedure? 8.Was the surgicel product left in place? was the excess removed? 9.Were cultures performed? if yes, results? 10.Has any surgical or medical intervention been performed? 11.What is physician¿s opinion as to the cause of or contributing factors to this event? 12.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative infection? 13.What is the patient¿s current status? 14.What is the users experience w/ surgicel fibrillar and other hemostatic agents? 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 procedure on (b)(6) 2024 for lumbar disc herniation and absorbable hemostat was used to stop bleeding.Ten days after the surgery, the patient experienced poor wound healing and infection.On the 14th day after the surgery, the patient underwent debridement, irrigation, and drainage surgery.One week after the surgery, the patient recovered and was discharged from the hospital.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6.Type of investigation.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?--female, 42 years old.2.What were the diagnosis and indication for the index surgical procedure?-the patient underwent surgery in our hospital due to lumbar disc herniation on (b)(6) 2024.Absorbable hemostat was used for hemostasis during surgery.The patient had poor wound healing with infection 10 days after surgery.The patient underwent debridement, lavage and drainage in our hospital on (b)(6) and was recovered and discharged 1 week after surgery.3.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically?-- address active bleeding.4.Has any surgical or medical intervention been performed?-the patient underwent debridement, lavage and drainage in our hospital on (b)(6) and was recovered and discharged 1 week after surgery.5.What is physician¿s opinion as to the cause of or contributing factors to this event? patient recent low resistance 6.What is the patient¿s current status? was recovered and discharged 1 week after surgery.7.What is the users experience w/ surgicel fibrillar and other hemostatic agents? normal.The following information was requested, but unavailable: 1.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 2.Was there any intraoperative concurrent use of other products? 3.Where was the surgicel used (on what tissue)? 4.How much surgicel was used during the procedure? 5.Was the surgicel product left in place? was the excess removed? 6.Were cultures performed? if yes, results? 7.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative infection? 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.

• Brand Name: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM)
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19134432
• MDR Text Key: 340500576
• Report Number: 2210968-2024-04512
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031003118
• UDI-Public: 10705031003118
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: 1961
• Device Lot Number: TFB8341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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