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 Abscess (1690); Hemorrhage/Bleeding (1888)

Event Type  Injury  

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.Additional information was requested, and the following was obtained: - what is the procedure date? - not clear, either (b)(6) 2020 or (b)(6) 2020.- what date was the abscess noticed? 4-5 days after the procedure (b)(6) 2020 or (b)(6) 2020).- was the drain placed during the initial procedure? round drain (non-jnj product) was placed during the initial procedure.- was there any medical or surgical intervention performed to treat the abscess (product removed; re-operation; antibiotics prescribed)? the abscess was treated with antibiotics.- what is the most current patient status? patient is out from the hospital and safe.The ureter was removed and changed for implant, so probably there was a leak.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.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? what were the diagnosis and indication for the index surgical procedure? 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.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? where was the surgicel used (on what tissue)? how much surgicel was used during the procedure? was the surgicel product left in place? was the excess irrigated and removed? what were current symptoms following the index surgical procedure? onset date? were cultures performed? if yes, results? has any surgical or medical intervention been performed? what is physician¿s opinion as to the etiology of or contributing factors to this event? was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative abscess? what was the drug therapy used for the patient¿s abscess? 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 hemicolectomy procedure on an unknown date and absorbable hemostat was used.The surgeons applied absorbable hemostat in the patient, and bleeding was stopped.Concern arose from the surgeon that during post-operative care a dark substance came out form patient through the drain, and abscess was observed.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/5/2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's 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 POWDER CE - ABSORBABLE HEMOSTATIC PWDR
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10946863
• MDR Text Key: 219557491
• Report Number: 2210968-2020-09585
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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: 05/31/2021
• Device Catalogue Number: 3023SP
• Device Lot Number: PPBATS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention