MAUDE Adverse Event Report: ETHICON INC. SURGICEL POWDER CE - ABSORBABLE HEMOSTATIC PWDR; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 3023SP

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

Patient Problems Burn(s) (1757); Necrosis (1971); Pain (1994); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a reconstructive skin surgery procedure on an unknown date and absorbable hemostat was used.A surgical flap procedure is performed on the face where the specialist decided to apply the absorbable hemostat subcutaneously and days after the procedure the specialist manifests burn and necrosis in the patient's tissue where he applied the product.The patient also experienced.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint #
=
> pc-001306310 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.The patient demographic info: age, gender, weight, bmi at the time of index procedure? 2.Date and name of index surgical procedure? 3.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.Any intraoperative concurrent use of other products? 6.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? 7.Where was the surgicel used (on what tissue)? 8.How much surgicel was used during the procedure? 9.Was the surgicel product left in place? was the excess irrigated and removed? 10.What were current symptoms following the index surgical procedure? onset date? 11.Has any surgical or medical intervention been performed? please describe.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 necrosis? 14.What is the patient¿s current status? 15.Please clarify the appearance of the wound.16.Please clarify what is meant by ¿burn¿.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 was requested, and the following was obtained: what happened was that the surgeon was performing a plastic surgery and did a very thin dissection of the superficial tissues, then the patient she had a bleeding and he put the surgicel all over the internal space under the skin without removing excess material.He accepted that he neither knew how to use the product neither read the ifu.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: h6.Health effect - clinical code - e1704.

Manufacturer Narrative

Product complaint # (b)(4).Additional information a 2.Patient age at the time of event, a 2.Age unit, a 3.Gender, b 7.Medical history/preexisting condition, h 6.Health effect - clinical code additional information was requested, and the following was obtained: 1.The patient demographic info: age, gender, weight, bmi at the time of index procedure? age: 62; gender: female; 2.Date and name of index surgical procedure? scar revision in face, (b)(6) 2023 3.The diagnosis and indication for the index surgical procedure? retraction in face following lifting surgery 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.No allergies.Lymphoma hodkin´s.She was not in medication.5.Any intraoperative concurrent use of other products? there was not any other product applied with surgicel powder.6.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? the surgeon refers that he used surgicel powder to control oozing bleeding that was not seen easily because of the small surgical incision.He also decided to leave surgicel powder in the patient prophylactically.7.Where was the surgicel used (on what tissue)? surgicel powder was applied subcuticular, on soft tissue under the skin, just under the skin graft.8.How much surgicel was used during the procedure? the entire contents of the syringe (3 gram).9.Was the surgicel product left in place? was the excess irrigated and removed? surgicel powder was left in place, and the surgeon did not irrigate to remove the excess.10.What were current symptoms following the index surgical procedure? onset date? the patient referred the next day of the surgery early signs of necrosis ((b)(6) 2023).Those signs were redness, swelling and darkening of the skin, pain.11.Has any surgical or medical intervention been performed? please describe.He decided to stop healings, wait until crust felt to make a new surgery for primary wound closure and rotation of local skin graft ((b)(6) 2023) 12.What is physician¿s opinion as to the etiology of or contributing factors to this event? at the beginning he considered that surgicel powder was guilty of this complication.However, after talking with the surgeon, it was concluded by him and our team that the problem was misuse of the product influenced by the nurse.He considered that surgicel powder was not indicated for his patient.13.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative necrosis? no.14.What is the patient¿s current status? currently the wound and the scar are healing properly.She feels more calm and understands her complication.15.Please clarify the appearance of the wound.Redness, swelling and darkening of the skin.16.Please clarify what is meant by ¿burn.It was the terminology used by the surgeon to describe the appearance of the wound, the next day of the surgery.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 POWDER CE - ABSORBABLE HEMOSTATIC PWDR
• 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: 16585774
• MDR Text Key: 311737952
• Report Number: 2210968-2023-01869
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2023

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 3023SP
• Device Lot Number: SDBEUT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 03/30/2023; 05/10/2023
• Supplement Dates FDA Received: 04/06/2023; 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Female