MAUDE Adverse Event Report: ETHICON INC. SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, STEEL

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

Patient Problems Inflammation (1932); Local Reaction (2035)

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: weight, bmi at the time of index procedure.The patient is (b)(6) 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.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date approximately 20 years ago and stainless steel suture was used.Recently 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.

• Brand Name: SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10907012
• MDR Text Key: 219171343
• Report Number: 2210968-2020-09313
• Device Sequence Number: 1
• Product Code: GAQ
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2020
• 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 Age: 70 YR