MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 5 S/A V-40; SUTURE, NONABSORBABLE, STEEL

Model Number M650G

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 11/18/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiovascular surgery on an unknown date and suture was used.It was stated the patient had the cardiovascular surgery long time ago.After the procedure, the patient experienced allergic symptoms on the skin which was described as an allergic reaction to eczema such as itching occurred throughout the body.The patient visited a dermatologist who suspected that the allergic symptoms were caused by the needle because the patient had a metal allergy to iron.The patient is under treatment with oral medicines for allergy and ointments.The patient visits to the hospital regularly.Additional information was requested.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Device not returned.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 patient's demographic information including age, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? lot number? patient symptoms- describe the manifestation of reaction (location, severity, appearance, systemic or local reaction)? onset date? what was the onset date, time from the index surgery? was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? other relevant patient history/concomitant medications? was medical intervention required to treat the patient condition? results.What oral medicines and ointments was the patient treated with? does the patient have known allergic history to medical device, food or medications? was there any allergy testing performed? if yes, results? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

Manufacturer Narrative

Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information was requested and the following was obtained: * please provide procedure date =>the doctor commented that the surgical steel was used a long time ago.No further information is available.* please provide lot number =>unknown.* was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? =>unknown.* was there any medical or surgical intervention performed to treat the allergic reaction(re-operation; re-suturing; prescription steroids; antibiotics prescribed)? =>the patient is being treated with oral medicine for allergy and ointment.* what is the most current patient health status and condition? =>the patient visits to the hospital regularly.

Manufacturer Narrative

(b)(4).Date sent to the fda: 1/25/2022.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information was requested and the following was obtained: please provide the patient's demographic information including age, weight, bmi at the time of index procedure female.Date and name of index surgical procedure? procedure:unknown but cardiovascular surgery.Date: doctor said ""it was carried out a long time ago."" the diagnosis and indication for the index surgical procedure? unknown.Lot number? unknown.Patient symptoms- describe the manifestation of reaction (location, severity, appearance, systemic or local reaction)? onset date? an allergic reaction to eczema such as itching occurred throughout the body.Onset date is on (b)(6).What was the onset date, time from the index surgery? onset date is on (b)(6).Was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? unknown.Other relevant patient history/concomitant medications? unknown.Was medical intervention required to treat the patient condition? results the patient is under treatment with oral medicines for allergy and ointments.What oral medicines and ointments was the patient treated with? unknown.Does the patient have known allergic history to medical device, food or medications? the patient has metal allergy to iron.Was there any allergy testing performed? if yes, results? unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the allergic reaction may be caused by the needle because the patient had a metal allergy to iron.What is the patient's current status? the patient visits to the hospital regularly.We are going to continue keep catching up with this case for a while.

• Brand Name: STLESS STEEL SIL 4X18IN 5 S/A V-40
• Type of Device: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12908293
• MDR Text Key: 281508276
• Report Number: 2210968-2021-12212
• Device Sequence Number: 1
• Product Code: GAQ
• UDI-Device Identifier: 10705031045439
• UDI-Public: 10705031045439
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M650G
• Device Catalogue Number: M650G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female