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

Model Number SXPP1A405

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pocket Erosion (2013)

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # date sent to the fda: 01/05/2022 component code: g07002 - device not returned.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: quantity of blood loss? patient weight? was there any medical or surgical intervention performed (re-operation; re-suturing; re-closure; drainage)? if so, please specify.Could you tell me if there was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.What was the appearance of the suture during the removal? was reoperation necessary to remove the suture and re-close the wound? was the suture trimmed in physician¿s office? was the suture removed in a routine post-op procedure? was the suture removed in a reoperation procedure? what is the current status of the patient? 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.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and barbed suture was used.After the surgery, the doctor used suture to sew the patient's wound.The patient found vaginal bleeding after the surgery and found that the patient's suture was not absorbed.The doctor removed the suture.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 2/7/2023.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.The following additional information was received: after investigation, the patient underwent uterine stump suture in (b)(6) 2022 (specific operation date was unknown) (specific patient diagnosis and operation method were unknown).The operator used the sxpp1a405 for vaginal stump sewing in the way of continuous suturing.The intraoperative suture operation was smooth.On (b)(6) 2022, the patient developed vaginal oozing (other accompanying symptoms were unknown).After examination, the doctor found that the involved suture product was not absorbed (specific examination method was unknown).Therefore, the doctor removed the suture from the patient (removal method and other treatment measures were unknown).No subsequent adverse events were reported.

• 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: 16108123
• MDR Text Key: 308652920
• Report Number: 2210968-2023-00113
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: SXPP1A405
• Device Catalogue Number: SXPP1A405
• Device Lot Number: SBMKDD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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: 40 YR
• Patient Sex: Female