MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 18IN 2-0 SA SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A409
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).H6 component code: g07002 - device not returned.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 information was requested, but unavailable: was there any medical or surgical intervention performed ( re-operation; product removal: re-closure: medication)? if so, please specify.Was a prescription for steroids or antibiotics issued for the patient's recovery? if yes, please provide the medication name, route, and dose.Please clarify: are there any plans in place to remove the suture/s in the future? if so, could you please provide the scheduled date for the removal? will the suture/s be removed in a routine post-op procedure? will the suture/s be removed in a reoperation procedure? will the suture/s be trimmed in the physician¿s office? if re-suturing/re-closure will be performed: was reoperation necessary to remove the sutures and re-close the wound? what is the current patient status? received information as following from reporter via phone today.Please refer to the event description, other information requested is unknown.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 reviewed.: the involved suture code should be sxpp1a409 with lot rdmetr.
Event or Problem Description
It was reported that a patient underwent an unknown plastic surgery on an unknown date and barbed suture was used.The patient did thread lifting surgery, and feedback postoperative facial swelling, uneven and suspect the barb was not hanged into tissue.And suspect the suture is sxpp1a409 or sxpp1a101.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.

• Brand Name: SFXSYM PDS+ UNI VIO 18IN 2-0 SA SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22523199
• Report Number: 2210968-2025-08218
• Device Sequence Number: 8011247
• Product Code: NEW
• UDI-Device Identifier: 10705031227729
• UDI-Public: (01)10705031227729(17)230331(10)RDMETR
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: SXPP1A409
• Device Lot Number: RDMETR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 07/20/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown