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 Inflammation (1932); Local Reaction (2035); Skin Irritation (2076); Not Applicable (3189)

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.The patient demographic info: age, weight, bmi at the time of index procedure date and name of the index surgical procedure where ethicon stainless steel suture was used? the diagnosis and indication for the index surgical procedure? was ethicon stainless steel suture, m650g, used in the surgery 30 years ago and also in the surgery 20 years ago? if yes, please provide dates of these surgeries on what tissue was ethicon m650g suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? what were the current symptoms following the index surgical procedure? onset date from the surgery? other relevant patient history/concomitant medications lot # of m650g.If applicable, will product be returned, return date, tracking information? what is the patient¿s current status?.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.It was reported that the suture was used for sternum closure in coronary artery bypass grafting and that the patient underwent cardiovascular surgeries twice in the past, about 20 years ago and about 30 years ago.The patient experienced inflammation reaction on the skin.The patient visited the outpatient clinic due to prurigo and is currently hospitalized due to worsening symptoms.There were no symptoms on the epidermis, but there were deep site symptoms, and the surgeon opined drugs and metals as one of the causes of prurigo as it may be caused by metal.The surgeon prescribed steroids, but they didn't work, so the surgeon thought that the cause remained.The patient underwent patch testing and sensitization to manganese chloride was confirmed.The surgeon opined that the suture contains manganese chloride and could not be excluded as a possible cause.The surgeon opined that drugs are the most suspicious, but would like to make a comprehensive judgment.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 11/25/2020.Additional information was requested and the following was obtained: the patient demographic info: weight, bmi at the time of index procedure: the patient is 70 years old male.Date and name of the index surgical procedure where ethicon stainless steel suture was used? the procedure is coronary artery bypass grafting.The procedure date is unknown.Was ethicon stainless steel suture, m650g, used in the surgery 30 years ago and also in the surgery 20 years ago? yes.It is unknown whether it is true because it is just doctor's comment (memory).Surgery dates are unknown on what tissue was ethicon m650g suture used? for sternum closure.If applicable, will product be returned, return date, tracking information? no sample will be returned.What is the patient¿s current status? the patient is hospitalized due to worsening symptoms.Did the patient undergo patch testing? yes.If yes, was sensitivity to manganese chloride confirmed as a result of the patch test? yes.The following information was requested but unavailable: the diagnosis and indication for the index surgical procedure? no further information is available.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? what were the current symptoms following the index surgical procedure? onset date from the surgery? other relevant patient history / concomitant medications lot#: of m650g.When was patch testing performed (date)? no further information is available.Note: events reported via mw 2210968-2020-08761, 2210968-2020-09313, 2210968-2020-09322.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: STLESS STEEL SIL 4X18IN 5 S/A V-40
• Type of Device: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10800822
• MDR Text Key: 215037174
• Report Number: 2210968-2020-08761
• Device Sequence Number: 1
• Product Code: GAQ
• UDI-Device Identifier: 10705031045439
• UDI-Public: 10705031045439
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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
• Date Manufacturer Received: 11/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR