MAUDE Adverse Event Report: ETHICON INC. SURGICEL FIBRILLAR 2INX4IN(5.1CMX10.2CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 1962

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Failure of Implant (1924); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 10/13/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown breast procedure on an unknown date in (b)(6) and absorbable hemostat was used.However an ultrasound showed the absorbable hemostat was not incompletely absorbed and second operation was performed (b)(6) 2023, to remove the product.Now the patient is in normal condition.Additional information was requested.

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 are the name and date of index surgical procedure? 3.What were the diagnosis and indication for the index surgical procedure? 4.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.5.Was there any intraoperative concurrent use of other products? 6.What is the lot number? 7.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? 8.Where was the surgicel used (on what tissue)? 9.How much surgicel was used during the procedure? 10.Was the surgicel product left in place? was the excess removed? 11.What were current symptoms following the index surgical procedure? onset date? 12.What is physician¿s opinion as to the etiology of or contributing factors to this event? 13.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative course? 14.What is the patient¿s current status? 15.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.

Manufacturer Narrative

Product complaint # (b)(4).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, 46 years old 2.What are the name and date of index surgical procedure? the first surgical procedure was bilateral breast segmentectomy under local anesthesia which was done in (b)(6) 2023.Two weeks after operation, the patient had hematocele and swelling in the left breast area.The hematoma was removed and the dressing was changed in the outpatient department.Two months after operation, the incision healed well.Three-dimensional ultrasound showed uneven mixed echo in the left breast.It was considered that it was not completely absorbed in 1962, and the patient required removal of the residual absorbable hemostat.3.What were the diagnosis and indication for the index surgical procedure? the first surgical procedure was bilateral breast segmentectomy under local anesthesia which was done in (b)(6) 2023.4.Was there any intraoperative concurrent use of other products? no 5.What is the lot number? tab0011 6.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? extensive wound oozing.7.Where was the surgicel used (on what tissue)? mastectomy wound.8.How much surgicel was used during the procedure? not tamponade.More intraoperative bleeding, 1962 all reacted with blood contact during surgery 9.Was the surgicel product left in place? was the excess removed? there was more intraoperative bleeding, and all of them reacted with blood contact during surgery.10.What were current symptoms following the index surgical procedure? onset date? the first surgical procedure was bilateral breast segmentectomy under local anesthesia which was done in (b)(6) 2023.Two weeks after operation, the patient had hematocele and swelling in the left breast area.The hematoma was removed and the dressing was changed in the outpatient department.Two months after operation, the incision healed well.Three-dimensional ultrasound showed uneven mixed echo in the left breast.Because surgicel was not absorbed for more than two months and ultrasound showed mixed echoes, through exploration, a second surgery was performed to remove it.11.What is physician¿s opinion as to the etiology of or contributing factors to this event? it was considered that it was not completely absorbed in 1962 12.What is the patient¿s current status?: good recovery.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 an alleged deficiency of the surgicel that contributed to the patient¿s post-operative course? 3.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.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested, and the following was obtained: the opposite side of the breast also have placed hemostatic gauze which is the same product, the product in opposite side was completely absorbed which did not find such problems.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 2INX4IN(5.1CMX10.2CM)
• 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17975561
• MDR Text Key: 326152501
• Report Number: 2210968-2023-08071
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031003125
• UDI-Public: 10705031003125
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2023

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: 1962
• Device Lot Number: TAB0011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 10/23/2023; 10/26/2023
• Supplement Dates FDA Received: 10/23/2023; 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2022
• 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: 46 YR
• Patient Sex: Female