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 Fever (1858); Unspecified Infection (1930); Inflammation (1932); Impaired Healing (2378)

Event Date 12/14/2023

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.Additional information was requested, and the following was obtained: 1.What were the diagnosis and indication for the index surgical procedure? posterior lumbar decompression, fusion and internal fixation under general anesthesia.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.Patient of advanced age with comorbid hypertension, usually in poor physical condition.3.Was there any intraoperative concurrent use of other products? cefmetazole sodium.4.What were current symptoms following the index surgical procedure? onset date? the patient underwent posterior lumbar decompression, fusion and internal fixation under general anesthesia due to lumbar spinal stenosis on (b)(6) 2023.Product 1961 was used intraoperatively to manage the bleeding.Product ms0010 was used to manage intraspinal bleeding.The postoperative wound healed well, with persistent fever and increased inflammatory parameters after removal of the drainage tube.It was considered to have wound infection, and the patient was given upgraded antibiotics and ultrasound-guided catheter drainage, but the effect was poor.The patient underwent wound debridement, suture perfusion, irrigation and drainage under general anesthesia on (b)(6) 2024, and recovered well after operation.5.What is physician¿s opinion as to the cause of or contributing factors to this event? relate to patient, patient of advanced age with comorbid hypertension, usually in poor physical condition.6.What is the patient¿s current status? recovered well after operation.7.What is the users experience w/ surgicel fibrillar and other hemostatic agents? the patient underwent posterior lumbar decompression, fusion and internal fixation under general anesthesia due to lumbar spinal stenosis on (b)(6) 2023.Product 1961 was used intraoperatively to manage the bleeding.Product ms0010 was used to manage intraspinal bleeding.The postoperative wound healed well, with persistent fever and increased inflammatory parameters after removal of the drainage tube.It was considered to have wound infection, and the patient was given upgraded antibiotics and ultrasound-guided catheter drainage, but the effect was poor.The patient underwent wound debridement, suture perfusion, irrigation and drainage under general anesthesia on (b)(6) 2024, and recovered well after operation.8.Was the cause of the infection identified? physician's opinion: relate to patient, patient of advanced age with comorbid hypertension, usually in poor physical condition.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.Was the surgicel product left in place? was the excess removed? 4.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative infection and poor wound healing? 5.Was surgiflo removed or left in the patient after hemostasis was archived? 6.Is surgiflo expected to be the cause or contributed to the event by the surgeon? 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 posterior lumbar decompression, fusion and internal fixation under general anesthesia due to lumbar spinal stenosis on (b)(6) 2023 and absorbable hemostat was used.The doctor used absorbable hemostat and fluid gelatin during the surgery to treat intraspinal hemorrhage.The postoperative wound healed well, with continuous fever and elevated inflammatory markers after removing the drainage tube.Considering wound infection, upgraded antibiotics were given and ultrasound-guided catheterization was performed for drainage, but the effect was not satisfactory.The surgery was performed on the 42nd day after surgery, and the postoperative recovery was good.Additional information was requested.

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.

• 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: 18897550
• MDR Text Key: 337590618
• Report Number: 2210968-2024-03025
• 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: 04/09/2024

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: SPE5781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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: 73 YR
• Patient Sex: Female