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 Wound Dehiscence (1154); Unspecified Infection (1930); Inflammation (1932); Fluid Discharge (2686)

Event Date 11/19/2023

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.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.What were the diagnosis and indication for the index surgical procedure? 2.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.3.Was there any intraoperative concurrent use of other products? 4.Please confirm that surgiflo was used.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.How much surgiflo was used? 9.Was the surgicel product left in place? was the excess removed? 10.Was surgiflo removed after hemostasis was achieved? 11.Was the surgicel fibrillar packed in the application area? 12.What were current symptoms following the index surgical procedure? onset date? 13.Has any surgical or medical intervention been performed? 14.What is physician¿s opinion as to the cause of or contributing factors to this event? 15.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative day 9 wound exuding red fluid? 16.What is the patient¿s current status? 17.What is the users experience w/ surgicel fibrillar, surgiflo 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 for lumbar spondylolisthesis on (b)(6) 2023 and absorbable hemostat was used.During the surgery, the doctor used absorbable hemostatic fluid gelatin and absorbable hemostat.The patient was discharged smoothly after surgery, and 9 days after surgery, the wound exuded red fluid.A second surgery consisting of debridement, perfusion, and drainage was performed to remove the lesion and sensitive antibiotics were used for anti-infection treatment.Currently, inflammation is effectively controlled.The patient's wound healed and was discharged.Additional information was requested.

Manufacturer Narrative

Product complaint (b)(4) additional information was requested, and the following was obtained: 1.What were the diagnosis and indication for the index surgical procedure? lumbar spondylolisthesis 2.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.On (b)(6) 2023 is first surgery date, other info is unknown 3.Was there any intraoperative concurrent use of other products? ms0010 and 1961, other products were unknown 4.Please confirm that surgiflo was used.Yes 5.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? to address active bleeding 6.What were current symptoms following the index surgical procedure? onset date? on postoperative day 9, the patient had wound exudation, red liquid, and wound dehiscence of 2 cm, and was discharged after debridement, perfusion and drainage for healing 7.Has any surgical or medical intervention been performed? a second operation was performed for debridement of the lesion and anti-infection treatment with sensitive antibiotics.Currently inflammation is effectively controlled.8.What is physician¿s opinion as to the cause of or contributing factors to this event? staphylococcus epidermidis infection.The patient had poor resistance after surgery, leading to infection with opportunistic pathogens.9.What is the patient¿s current status? was discharged the following information was requested, but unavailable: 1.Where was the surgicel used (on what tissue)? 2.How much surgicel was used during the procedure? 3.How much surgiflo was used? 4.Was the surgicel product left in place? was the excess removed? 5.Was surgiflo removed after hemostasis was achieved? 6.Was the surgicel fibrillar packed in the application area? 7.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative day 9 wound exuding red fluid? 8.What is the users experience w/ surgicel fibrillar, surgiflo and other hemostatic agents? 9.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative day 9 wound exuding red fluid? 10.What is the users experience w/ surgicel fibrillar, surgiflo 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.

Manufacturer Narrative

Product complaint #
=
> (b)(4) additional information: h6.Health effect - clinical code 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).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).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: 18537124
• MDR Text Key: 333160593
• Report Number: 2210968-2024-00501
• 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,Followup,Followup,Followup
• Report Date: 03/05/2024

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: TJE1011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 01/22/2024; 01/22/2024; 02/02/2024; 02/12/2024
• Supplement Dates FDA Received: 01/22/2024; 01/24/2024; 02/07/2024; 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male