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

Catalog Number	VR917
Medical Device Problem Codes	Break (1069); Failure to Degrade (4084)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	11/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent a post op vaginal delivery suture removal on (b)(6) 2025 a suture was used.The patient came to the hospital for vaginal delivery nov.10 and felt that the perineal suture was prone to tearing during the delivery room.On the 6th day after surgery, the patient came to the hospital to remove the wound suture.During the operation, the doctor and nurse found that the patient's wound had not healed/had poor healing, and the absorbable gap had broken.Immediately clean the residual gaps, disinfect with iodine solution, guide the patient to soak in iodine solution for disinfection, provide dietary guidance, and recheck 7 days later.The wound has healed well.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint(b)(4).Additional information: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.* did the patient experience a wound dehiscence? - if the suture was removed: ¿ was the suture removed in a reoperation procedure? ¿ 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? - was a prescription for steroids or antibiotics issued for the patient's recovery? if so, please provide the medication name, route, and dosage.- any photos available for visual analysis? - please inform the patient¿s current health status and condition.- please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).--received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.- please provide the lot number.The lot number is unknown.No product is available for return.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.

• 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.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24594972
• Report Number: 2210968-2026-02593
• Device Sequence Number: 9158241
• Product Code: GAM
• UDI-Device Identifier: 10705031134768
• UDI-Public: 10705031134768
• 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): 03/13/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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