MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 3-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	VCP442H
Medical Device Problem Code	Failure to Degrade (4084)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/20/2026 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: what is the current status of the patient? - 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.Was it necessary to perform any additional procedure besides the removal? for example, suturing, reoperation, etc.? if so, where was this procedure carried out? in a medical office, in an operating room, etc.? received information as following from sales rep 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.
Event or Problem Description
It was reported that a patient underwent a vaginal delivery on (b)(6) 2025 and suture was used.Post-op inflammation.The patient gave birth vaginally and experienced perineal tears during the delivery process.The wound was sutured cosmetically with suture (intradermally suture) and the suturing process went smoothly.The patient began to experience perineal pain 12 days after surgery, and upon examination, it was found that the intradermal suture was exposed.After removing the suture, the patient's symptoms improved.25 days after surgery, the patient found that the suture had been discharged again, and the perineal wound was red with pain and discomfort.After removing some visible sutures, the patient's pain symptoms were significantly relieved.The wound healed as scheduled.Additional information was requested.

• Brand Name: VCL+ UD 27IN 3-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24118352
• Report Number: 2210968-2026-00722
• Device Sequence Number: 14937749
• Product Code: GAM
• UDI-Device Identifier: 10705031053298
• UDI-Public: (01)10705031053298(17)300331(10)107RQA
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K181652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: VCP442H
• Device Lot Number: 107RQA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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