MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X18IN 2-0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP839D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an unknown procedure on unknown date and the suture was used.It was reported that the patient experienced abscess suture abscesses week 7 to 10 post op approximately.The patient was treated with oral antibiotic, muprocin, and cleaning with peroxide.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.(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.The patient demographic info: age, gender, weight, bmi at the time of index procedure? date, name and/or indication of index surgery? product lot number? on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? were there any pre-existing signs/symptoms of active inflammation/infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were any pre-op cleansing procedures or products changed recently? if yes, please describe.It was reported in (b)(4) that ¿some patients have returned with suture spitting issues¿.Did additional reported 9 patients with abscess also experience suture spitting issue? if yes, please clarify/specify.Did the operating surgeon observe any suture deficiency or anomaly before, during and/or after the suture placement? please specify.Patient symptoms manifestations of abscess (location, severity, appearance).Were cultures performed? results? other relevant patient history/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength = 275 ¿g/m.

• Brand Name: VCL+ UD 8X18IN 2-0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12595572
• Report Number: 2210968-2021-09366
• Device Sequence Number: 19650784
• Product Code: GAM
• UDI-Device Identifier: 10705031055766
• UDI-Public: 10705031055766
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: VCP839D
• Device Catalogue Number: VCP839D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention