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 Problem Peritonitis (2252)

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.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, weight, bmi at the time of index procedure? what was the date of index surgical 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.Was there any intraoperative concurrent use of other products? what is the lot number? 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 there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative peritonitis? were cultures performed? if so, what were the results.What is the patient¿s current status?.

Event Description

It was reported that a patient underwent a laparotomy ovarian malignant tumor procedure on an unknown date and absorbable hemostat was used.After the procedure there was a finding of peritonitis.The patient was followed up with drainage and has been discharged from the hospital.All hemostatic agents were sprayed, and no washing was performed.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 8/4/2021.Additional information was requested, and the following was obtained: 1.Please provide the following patient demographic information, if available: age, weight, bmi at the time of index procedure? female.2.What was the date of index surgical procedure? no further information is available.3.What were the diagnosis and indication for the index surgical procedure? malignant tumor.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 further information is available.5.Was there any intraoperative concurrent use of other products? no further information is available.6.What is the lot number? no further information is available.7.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? no further information is available.8.Where was the surgicel used (on what tissue)? intraperitoneal.9.How much surgicel was used during the procedure? whole amount was used.10.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative peritonitis? no further information is available.11.Were cultures performed? if so, what were the results.No further information is available.12.What is the patient¿s current status? the patient has been discharged from the hospital.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
• MDR Report Key: 12135494
• MDR Text Key: 260694934
• Report Number: 2210968-2021-06122
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031237506
• UDI-Public: 10705031237506
• 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: 07/01/2021

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
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 08/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention