MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 2-0 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP917H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Abscess (1690); Impaired Healing (2378); Post Operative Wound Infection (2446)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient delivered spontaneously on (b)(6) 2020 and suture was used to suture torn right labia majora.The patient experienced poor wound healing.One month later, about 1.5 cm abscess appeared at the suture site, and multiple debridement was performed; repeated one week later and two weeks later, and wound has not healed yet.
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: did the operating surgeon observe any suture deficiency or anomaly before, during the suture placement and/or during debridement procedures? not mention.What type of debridement was performed? was it required anesthesia additionally? please specify.Wound infection to form a pus cavity, the first incision of the pus cavity to remove pus, cut off visible suture; the wound was re-exposed for a second time and drained.Other relevant patient factors/comorbidities/concomitant medications? no.What is physician¿s opinion as to the etiology of or contributing factors to this event (abscess and poor wound healing)? absorption of suture for too long and maternal physical fitness related to the formation of infection.What is the patient¿s current status? discharged from hospital.Additional information was provided: the product code involved are vcp422h and vcp917h (both lot number are unknown).The following information was requested, but unavailable: the patient demographic info: weight, bmi at the time of index procedure? please clarify lot number? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? was any prescribed medication required for treatment? please specify.Were cultures performed? results? note: events reported in 2210968-2021-00157.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 g/m.

• Brand Name: VCL+ UD 36IN 2-0 S/A V-34
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ
• MDR Report Key: 14103144
• Report Number: 2210968-2022-02645
• Device Sequence Number: 4676853
• Product Code: GAM
• UDI-Device Identifier: 10705031056039
• UDI-Public: 10705031056039
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VCP917H
• Device Catalogue Number: VCP917H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female