MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 6 S/A V-40; SUTURE, NONABSORBABLE, STEEL

Model Number M649G

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Swelling/ Edema (4577)

Event Date 07/31/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent attempts are being made to receive additional information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was the patient aware of her nickel allergy prior to open heart surgery? does ethicon have your permission to contact your surgeon/doctor, in the event ethicon would like to contact your surgeon/doctor for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon/doctor¿s contact information? if in your possession, may we have copies of your operative report, any examinations and allergy test?.

Event Description

It was reported that the patient underwent an open-heart surgery on (b)(6) 2021 and the suture was used for sternum closure.A couple days post op, graft disintegrated.The patient is quarantined for 5 months.It was also reported that the patient has broken out in severe rash and the only thing to do is to wait for the sternum to heal with is five months and then to remove the wire which they are assuming contains nickel.The patient stated that three days she developed little bumps, but the nurse thought that it was the nerve endings coming back from the trauma from opening the chest.After the patient returned home, she had a heart attack because of an unattached vessel.Rash was not treated during her second trip to the hospital and when the patient returned home again, the rash moved around body, neck around ears, into ears, across cheek and on eye lids.It was reported that everything is red, itchy and swollen.The allergy patch test was done on (b)(6) 2021 and patient is waiting for results.Additional information has been requested.

• Brand Name: STLESS STEEL SIL 4X18IN 6 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: 12453129
• MDR Text Key: 270848325
• Report Number: 2210968-2021-08277
• Device Sequence Number: 1
• Product Code: GAQ
• UDI-Device Identifier: 10705031045415
• UDI-Public: 10705031045415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

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: Health Professional
• Device Model Number: M649G
• Device Catalogue Number: M649G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 09/30/2021
• 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