MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X18IN 4-0 S/A RB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP714D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Impaired Healing (2378); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 g/m.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation:citation: jul.2020 vol.32 no.7 article id: 1672-7134 (2020) 07-0739 clc: r271.9 literature marking code: b doi: 10.16448/j.Cjtcm.2020.0739.
Event or Problem Description
Title: compound radix sophorae flavescentis lotion irrigation combined with thunderbolt moxibustion for poor healing of episiotomy.This study aims to evaluate the clinical effect of compound kushen lotion irrigation combined with thunderbolt moxibustion in the treatment of poor healing of lateral episiotomy from january 2018 to september 2019, 125 parturients, average years the age was (24 ± 2.3) years, with poor healing of lateral episiotomy, where 4/0 absorbable suture (antibacterial vicryl absorbable suture, vcp714d johnson & johnson, usa) continuous suture) was used, for vaginal delivery who met the criteria were randomly divided into the control group (n=62) cases and the test group (n=63) cases.Reported complications included: (n=125) parturients with poor healing of lateral episiotomy.62 cases in the control group was given potassium permanganate solution 1:5000 heated to 35-43 sitz bath, once a day, combined with magnesium sulfate wet compress, far infrared irradiation will negative for 20 min.63 cases in the test group were given compound kushen lotion (heated to 35-43) the perineum was washed once a day, combined with thunderbolt moxibustion suspension moxibustion for 20 min, once a day 7 days as a course of treatment.(n=?) infection exudation pus , dehiscence, alignment head row repellent the surgical site, give 0.5% iodophor solution to clean the surgical site, remove the suture, after removal of pus and necrotic tissue, 2 different methods were then used for treatment.(n=?) pain and edema of perineal wound.It was concluded , that compound radix sophorae flavescentis lotion irrigation combined with thunderbolt moxibustion in the treatment of poor healing of perineal wound can effectively relieve the pain and edema of perineal wound, reduce the secretion of wound, shorten the healing time of wound and promote the healing of perineal wound.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 8/4/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.The following information was requested but unavailable: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.

• Brand Name: VCL+ UD 8X18IN 4-0 S/A RB-1 CR
• 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 08869 ; 9083863534
• MDR Report Key: 15112324
• Report Number: 2210968-2022-05973
• Device Sequence Number: 5553898
• Product Code: GAM
• UDI-Device Identifier: 10705031055018
• UDI-Public: 10705031055018
• 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: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: VCP714D
• Device Catalogue Number: VCP714D
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown