MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CT; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A405

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)

Event Date 11/11/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a myomectomy procedure on (b)(6) 2022 and barbed suture was used.During the procedure, the doctor used suture to sew the stripped surface of uterine leiomyoma.When the suture reached about 2/3 of the uterine wound the suture was broken, causing the patient's uterine wound to rupture and oozing.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.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.The following information was requested, but unavailable: what is meant by uterine wound to rupture? was the uterine wound rupture and oozing controlled intra-op with re-suturing with a new suture? was any medical or surgical intervention required for the event other than using a new suture to complete the procedure? was the patient¿s treatment or post-operative care altered in anyway due to suture breaking intra-op? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the suture breakage intra-op? were there any adverse patient consequences? what is the patient¿s current status? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ¿g/m.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15974324
• MDR Text Key: 307275633
• Report Number: 2210968-2022-10232
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227682
• UDI-Public: 10705031227682
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: SXPP1A405
• Device Catalogue Number: SXPP1A405
• Device Lot Number: RCMKCR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female