MAUDE Adverse Event Report: ETHICON INC. SURGICEL SNOW 2INX4IN(5.1CMX10.2CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number 2082

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

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Fever (1858); Fluid Discharge (2686); Foreign Body In Patient (2687)

Event Date 10/03/2020

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: the patient demographic info: age, weight, bmi at the time of index procedure? both were young on early twenty.Relevant patient history? both were in labor and had problem.Any intraoperative concurrent use of other products? no.What is the lot #? pgb7121.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? there was no active bleeding , only minimal oozing.Where was the surgicel used (on what tissue)? uterine wall & bladder bed.How much surgicel was used during the procedure? one piece of surgicel snow 5.1*10.2 cm.Was the surgicel product left in place? was the excess irrigated and removed? it was left in place, the excess was not removed & not irrigated.What were current symptoms following the index surgical procedure? onset date? fever & abdominal pain within 5 days.Were cultures performed? if yes, results? no.Has any surgical or medical intervention been performed? yes, both cs were followed by exploratory laparotomy.What is physician¿s opinion as to the etiology of or contributing factors to this event? presence of surgicel snow as foreign body with presence of prolonged rupture of membranes & minimal oozing.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative infection, pain, fever, and wound dehiscence? n/a.What is the patient¿s current status? both were get well after laparotomy, symptoms were disappear.The single complaint was reported with multiple events.There are no additional details regarding the additional events.

Event Description

It was reported that a patient underwent a c-section on (b)(6) 2020 and absorbable hemostat was used.Post-surgery infection was reported along with an open wound upon incision site inspection, four days after surgery.The event required intervention to prevent permanent impairment damage.The patient also experienced pain and a high fever.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/23/2020.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.

• Brand Name: SURGICEL SNOW 2INX4IN(5.1CMX10.2CM)
• 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: 11017067
• MDR Text Key: 223372761
• Report Number: 2210968-2020-09977
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031063594
• UDI-Public: 10705031063594
• 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: 11/17/2020

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: No Information
• Device Expiration Date: 05/31/2021
• Device Model Number: 2082
• Device Catalogue Number: 2082
• Device Lot Number: PGB7121
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention