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

Model Number 3013SP

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

Patient Problems Rash (2033); Blister (4537)

Event Date 12/30/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a knee procedure on (b)(6) 2022 and absorbable hemostat was used.The product was used for osteotomy of knee.After the surgery, eruptions (blisters) appeared around the suture area.The patient was discharged from the hospital.The patient was discharged from the hospital.The surgeon commented that they don't know if it was caused by the absorbable hemostat or not, but there is a possibility that the washing was insufficient.Additional information was requested.

Manufacturer Narrative

Product complaint(b)(4).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: what is the procedure name? knee osteotomy.What is the procedure date (dd/mm/yyyy)? (b)(6) 2022.What date did the blisters occur on (dd/mm/yyyy)? (b)(6) 2022.How large of an area does the blistering reaction cover?the surgeon didn't know the detail area, but he said it was not large.Do you have any pictures of the blisters? the surgeon said he could not share the picture.The sales rep confirmed the picture that was taken in (b)(6) 2023 at the hospital and she seemed the rashes and blisters improved and looked like pigmentation.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Use of gentacin ointment.If medication was required, please clarify if it was prescription strength.The surgeon used the gentacin ointment and the symptom recovered.Can you identify the lot number of the product that was used? the sales rep could not look for the lot number because the device was discarded.What is the most current patient status? the patient is attending the hospital now.The surgeon followed-up with the patient in (b)(6) 2023.The surgeon said "i cannot say that the powder is the cause.I think i may have tightened the sutures too much.¿ primary disease: knee osteoarthritis.Patient background: no allergies.Meniscus suture was performed at another hospital 1 year ago".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.Was there any intraoperative concurrent use of other products? 4.How was the wound dressed? 5.What prep was used? 6.What kind of sutures were used? 7.What are the product code and lot number of the sutures? 8.What suture technique was used during closure? 9.How was the suture placed (interrupted or continuous)? 10.How was the suture originally tied (multiple knots, square knot, etc.)? 11.What is the lot number of the surgicel powder? 12.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? 13.Where was the surgicel used (on what tissue)? 14.How much surgicel was used during the procedure? 15.Was the surgicel product left in place? was the excess irrigated and removed? 16.Were cultures performed? if yes, results? 17.Has any surgical or medical intervention been performed, in addition to the use of gentacin ointment? 18.What is physician¿s opinion as to the etiology of or contributing factors to this event? 19.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative blisters and rash? 20.What is the patient¿s current status? 21.What is the users experience w/ surgicel powder 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? there is no allergy.The patient was conducted meniscus surgery in other hospital.2.What were the diagnosis and indication for the index surgical procedure? knee osteoarthritis.3.Was there any intraoperative concurrent use of other products? other hemostasis devices and medicine were not used in the operation.4.How was the wound dressed? gentacin ointment.5.What is the lot number of the surgicel powder? the sales rep did not know the lot number.6.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? it was used to address active bleeding.7.Where was the surgicel used (on what tissue)? side of bone cut off.8.How much surgicel was used during the procedure? 3g.9.Was the surgicel product left in place? was the excess irrigated and removed? the surgeon washed the side using surgicel powder, but he said the washing was insufficient.10.Were cultures performed? if yes, results? no, cultures were not performed.11.Has any surgical or medical intervention been performed, in addition to the use of gentacin ointment? only gentacin ointment.There was no other medical intervention.12.What is physician¿s opinion as to the etiology of or contributing factors to this event?=>¿i don't know if it was caused by surgicel powder or not, but there is a possibility that the washing was insufficient.¿ 13.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative blisters and rash? the surgeon's comment; i cannot say that the powder is the cause.I think i may have tightened the sutures too much.14.What is the patient¿s current status? the patient discharged from the hospital.15.What is the users experience w/ surgicel powder and other hemostatic agents? i'm not sure how many times the surgeon use surgicel powder, but this was not first time.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 prep (pre-op cleansing agent¿s) was used? 2.Were any pre-op cleansing procedures changed recently? if yes, please describe 3.What kind of sutures were used? 4.What are the product code and lot number of the sutures used during the procedure? 5.What suture technique was used during closure? 6.How was the suture placed (interrupted or continuous)? 7.How was the suture originally tied (multiple knots, square knot, etc.)? 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: was there any intraoperative concurrent use of other products? no hemostatic agent was used except for the complaint product.What kind of sutures were used? the sutures used were not ethicon products.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 USA - 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: 16368765
• MDR Text Key: 309467780
• Report Number: 2210968-2023-01026
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031237506
• UDI-Public: 10705031237506
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/27/2023

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 Model Number: 3013SP
• Device Catalogue Number: 3013SP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 03/20/2023; 04/21/2023
• Supplement Dates FDA Received: 03/21/2023; 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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