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

Catalog Number 3023SP

Device Problem Material Integrity Problem (2978)

Patient Problems Wound Dehiscence (1154); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 is the 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 irrigated and removed? 11.What were current symptoms following the index surgical procedure? onset date? 12.Has any surgical or medical intervention been performed? 13.What is physician¿s opinion as to the etiology of or contributing factors to this event? 14.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative dehiscence? 15.What is the patient¿s current status? 16.What is the users experience w/ surgicel powder and other hemostatic agents? 17.Is the surgeon attributing the dehiscence to the surgicel powder or did the patient experience the dehiscence and upon 18.In the surgeon¿s opinion did the powder have anything to do w/ the dehiscence 19.In the surgeon¿s opinion what is the impact of the surgicel powder in place.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 mastectomy procedure on an unknown date and absorbable hemostat was used.The surgeon sprayed the absorbable hemostat during mastectomy and patient had breast reconstruction with implants.However, due to wound dehiscence, the surgeon went in again to re-open the wound and remove the implant but found a gunk of absorbable hemostat even after more than one month.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h 6.Health effect - clinical code.Additional information was requested, and the following was obtained: 1.Was there any intraoperative concurrent use of other products? only surgicel powder for that bleeding site after the implant was placed.2.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? ensure hemostasis.3 was the surgicel product left in place? was the excess irrigated and removed? excess was irrigated.4.Has any surgical or medical intervention been performed? surgeon irrigated the powder gunk that did not absorb after 14 days.5.What is physician¿s opinion as to the etiology of or contributing factors to this event? unknown.6.What is the patient¿s current status? recovered well.7.What is the users experience w/ surgicel powder and other hemostatic agents? has used powder before but it tends to clog his drains post-op, so he prefers arista.8.Is the surgeon attributing the dehiscence to the surgicel powder or did the patient experience the dehiscence? surgeon did not attribute the dehiscence to powder.9.In the surgeons opinion did the powder have anything to do w/ the dehiscence no.10.In the surgeon¿s opinion what is the impact of the surgicel powder in place.Does not seem to work as stated since it does not absorb after 14 days even after excess irrigation.The following information was requested, but unavailable: 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.What are the product code and lot number? 6.Where was the surgicel used (on what tissue)? 7.How much surgicel was used during the procedure? 8.What were current symptoms following the index surgical procedure? onset date? 9.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative course? 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: can you share what was done to the surgical powder after the discovery? was it removed from the patient and how? the surgicel powder was removed from the patient after discovery.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: 16135275
• MDR Text Key: 307062181
• Report Number: 2210968-2023-00267
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 04/25/2023

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: 3023SP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 01/19/2023; 01/26/2023; 04/19/2023
• Supplement Dates FDA Received: 01/23/2023; 01/26/2023; 04/25/2023
• 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): Other