MAUDE Adverse Event Report: ETHICON INC. ETHILON BLUE NYLON SUTURE; SUTURE, NONABSORBABLE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Discharge (2225); No Code Available (3191)

Event Date 02/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.

Event Description

It was reported that the patient underwent a femoral graft procedure on (b)(6) 2017 and the suture was used for the lower leg incision closure.A traditional dressing was used over incision.The incision site was not red, hot or swollen.After the procedure, the patient was readmitted to the hospital due to sepsis.The patient was being treated according to standard practice.Additional information has been requested.

Manufacturer Narrative

Corrected date of event information: event date (b)(6) 2017 additional information: other relevant history.(b)(4).Additional information was requested and the following was obtained: requesting clarification of initial procedure date - the initial procedure date is (b)(6) 2017.Are there any products to return for analysis? no products to return.Initial procedure date (b)(6) 2017.Did the patient have a pre-existing infection? no pre-existing infection was noted.Date infection was noted? patient had a fever on (b)(6) 2017.Please indicate all medical or surgical interventions performed? no surgical interventions.Standard treatment for fever.No cultures or viral panels were performed.Results of any cultures taken: no cultures taken.Update to patient current condition patient was noted as ¿remarkedly improved¿ what is the physicians opinion was the sepsis related to the dermabond prineo? physician merely reported as such because of the fever.Patient pre-existing medical conditions (ie.History of infections) pre-existing graft what was the appearance of the lower leg incision when the dressing was placed? some drainage post op at this incision site.What date post op did the patient present with symptoms? patient presented with fever on (b)(6) do you have any photos of the 2 leg incisions? no photos taken.What is the surgeon opinion of the sepsis being related to the monocryl or ethilon suture or prineo? just mentioned fever presented post op what medical intervention was prescribed/ performed to treat the sepsis? no culture or viral panel was taken.Can you identify the product code of the ethilon suture? 4-0 ethilon ¿particular code not noted what tissue layer of the lower leg incision was the ethilon suture placed? skin.What was the condition of the lower leg tissue where the ethilon was placed? normal tissue.Was a culture performed on the lower leg tissue site where the ethilon was used? no culture or viral panel ever taken.What was the result of the culture? na.What medical intervention was prescribed/ performed to treat the sepsis? no culture or viral panel was taken.What is the current condition of the patient? noted patient has remarkedly improved.

• Brand Name: ETHILON BLUE NYLON SUTURE
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6397906
• MDR Text Key: 69734399
• Report Number: 2210968-2017-31111
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: PRINEO, MONOCRYL SUTURE
• Patient Outcome(s): Required Intervention