MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 36"(90CM) 2-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR917
Medical Device Problem Code	Failure to Degrade (4084)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Impaired Healing (2378)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a vaginal delivery on (b)(6) 2025 and suture was used.The patient gave birth to a baby girl at full term at 04:35 due to "40 * weeks of amenorrhea".The perineal incision was sutured smoothly without any other discomfort, and the patient was discharged 2 days later.32 days after the surgery, the patient came to the hospital for treatment due to "pain in perineum, unclean lochia and peculiar smell".The gynecological examination found poor healing of the perineal incision, visible exposed suture.The local vulva was cleaned and the suture was removed.Two bottles of compound phellodendron liquid coating were given to go home and wash the perineum.After 41 days of surgery, the patient returned to the hospital for postpartum rehabilitation evaluation, and the examination found that the vulva was normal.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/17/2025.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, 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.Additional information was requested; the following was obtained: was there any medical or surgical intervention performed (re-closure; prescription medication)? if so, please specify.If medication was required, please clarify if it was prescription strength.What is the most current patient status? 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.
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.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: VICRYL RAPIDE SUTURE 36"(90CM) 2-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23828989
• Report Number: 2210968-2025-14163
• Device Sequence Number: 9288609
• Product Code: GAM
• UDI-Device Identifier: 10705031134768
• UDI-Public: (01)10705031134768(17)300131(10)AW3799
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033746
• 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,Followup
• Report Date (Section B): 02/09/2026

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: VR917
• Device Lot Number: AW3799
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2025
• 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: Female