MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Erythema (1840); Fever (1858); Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 07/05/2022

Event Type  Injury  

Event Description

Title: tissue adhesive, adhesive tape, and sutures for skin closure of paediatric surgical wounds: prospective randomized clinical trial.The aim of this study was to compare three common skin closure techniques in children undergoing elective surgical procedures in a prospective rct.These included sutures with tissue adhesive, sutures with adhesive tape, and sutures alone.It was hypothesized that there would be no difference between the three intervention arms for evaluated endpoints.In this parallel randomised controlled trial, children (aged 18 years or less) undergoing elective general surgical or urological procedures were randomized to skin closure with sutures alone, sutures and adhesive tape, or sutures and tissue adhesive.Participants were assessed 2 weeks, 6 weeks, and more than 6 months after operation.Outcomes included wound cosmesis (clinician- and parent-rated) assessed using four validated scales, parental satisfaction, and wound complication rates.295 patients (333 wounds) were recruited and 277 patients (314 wounds) were included in the analysis.Vicryl® (polyglactin 910; ethicon, (b)(4), usa), coated vicryl rapide¿ (polyglactin 910; ethicon, (b)(4), usa), pds® ii (polydioxanone; ethicon), dermabond® topical skin adhesive (2-octylcyanoacrylate; ethicon, (b)(4), usa) were used.Reported complications included wound dehiscence, wound erythema, wound oedema, purulent discharge, or fever or positive wound swab culture, reopening of wound incision along line of sutures/skin closure.In conclusion short-term wound cosmesis was poorer with tissue adhesive although it is unclear whether this difference is sustained in the long-term.There were no differences between techniques for the study outcomes.

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.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? which specific ethicon products have been used during the procedures (product code, lot number)? 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.Patient demographics? 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.Related events captured via 2210968-2022-09456, 2210968-2022-09457, 2210968-2022-09459.Citation: bjs, 2022, 109, 1087¿1095 https://doi.Org/10.1093/bjs/znac254.

Manufacturer Narrative

(b)(4).Date sent to the fda: 11/18/2022 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 was requested, and the following was obtained: our rct examined wound closure techniques with derma bond, steristrips and tegaderm.It did not look at the suture as this was standardised between all 3 arms.There is no complaint? i have used ethicon products for a long time and have not concerns.Do you also know if there is a contact for potential sponsorship of sutures to our simulation centre? related events captured via 2210968-2022-09456, 2210968-2022-09457, 2210968-2022-09459.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• 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: 15798970
• MDR Text Key: 303669746
• Report Number: 2210968-2022-09458
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other