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

Catalog Number	VR917
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned.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: ¿ in addition to product removal, was there any medical or surgical intervention performed re-operation; re-suturing; re-closure; drainage)? if so, please specify.¿ was a prescription for steroids or antibiotics issued 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 the suture removed in a routine post-op procedure? ¿ was the suture removed in a reoperation procedure? ¿ if re-suture/re-closure was performed: - was reoperation necessary to remove the suture and re-close the wound? - was the suture trimmed in physician¿s office? ¿ what is the patient¿s current health status and condition? a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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.
Event or Problem Description
It was reported that a patient underwent a vaginal delivery procedure on (b)(6) 2025 and suture was used.The patient delivered a live baby vaginally.During delivery, there was a grade i perineal laceration.The doctor used suture to suture the perineal laceration and stop the bleeding.The suture process went smoothly, and the perineal wound was irradiated with infrared radiation and washed to maintain cleanliness and hygiene.On the third day after surgery, it was found that the perineal wound had poor healing, with poorly absorbed sutures and some exposed sutures.The exposed suture was removed.On the seventh day after surgery, the patient's perineal wound still had poor healing and new exposed suture was removed again.Considering that pregnant women may have vaginitis before delivery, vaginal bleeding after delivery can lead to poor wound healing and difficulty in absorbing suture.No adverse patient consequences were reported.Additional information was requested.

• 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: 22635703
• Report Number: 2210968-2025-08699
• Device Sequence Number: 15451179
• Product Code: GAM
• UDI-Device Identifier: 10705031134768
• UDI-Public: (01)10705031134768(17)290831(10)AV9535
• 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
• Report Date (Section B): 07/28/2025

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 Catalogue Number: VR917
• Device Lot Number: AV9535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• 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