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 Purulent Discharge (1812); Erythema (1840); Unspecified Tissue Injury (4559)

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to clarify 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 author/surgeon believe that ethicon products (vicryl suture, monocryl suture and pds suture) involved caused and/or contributed to post-operative complications described in the article (wound score of more than 0 which comprises of additional treatment serous discharge, erythema, purulent exudate, separation of deep tissues, and isolation of bacteria; subjective complaint on surgical incision)? please specify.Does the author/surgeon believe there was any deficiency with the ethicon products (vicryl suture, monocryl suture and pds suture) used in this procedure/study? please specify.If yes, please provide patient demographics for patients that experienced the post-operative complications (wound score of more than 0 which comprises of additional treatment serous discharge, erythema, purulent exudate, separation of deep tissues, and isolation of bacteria; subjective complaint on surgical incision) and details of events if available.Were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: journal of obstetrics and gynaecology, volume 41:3, pages 348-352, doi: 10.1080/01443615.2020.1736015.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2021-07259,and 2210968-2021-07261.

Event Description

Title: impact of timing on wound dressing removal after caesarean delivery: a multicentre, randomised controlled trial.The objective of the study was assessing wound healing at 24 versus 48 hours post caesarean delivery with a modified one-day asepsis score.This preliminary study will lead to further studies comparing wound complications and infections.Between april 2015 and march 2017, 869 low-risk obstetric patients aged 18+/-44 years with term, singleton pregnancies who underwent caesarean delivery were included in the study.Of which 430 patients (mean age 29.2+/-58 years and mean bmi 29.7+/- 4.2 kg/m2) were assigned to the 24-hour group and 439 patients (mean age 29.4+/- 5.5 years and mean bmi 30.0+/- 4.9 kg/m2) to the 48-hour dressing removal group.After the caesarean delivery procedure, polyglactin 910 vicryl suture (ethicon) or polydioxanone pdo suture (ethicon) were used for fascia closure in all patients.If subcutaneous depth was more than 2 cm, an approximation of tissue with 2-0 vicryl (ethicon) was used.Monocryl 2-0 (ethicon) was used for subcuticular closure of skin incisions.The incisions were covered with a competitors telfa, gauze pads and surgical tapes under a slight tension.Wound healing was assessed at 24 versus 48 hours post caesarian.Wounds were assessed by a one-day or two-day asepsis scoring method before hospital discharge, at the 1-week wound check clinical visit, and the routine 6-week postoperative visit.Complications included wound score of more than 0 which may comprise of additional treatment (drainage, antibiotics, debridement), serous discharge, erythema, purulent exudate, separation of deep tissues, and isolation of bacteria (24hr group n=136 and 48hr group n=143) upon discharge, (24hr group n=141 and 48hr group n=123) at 1 week evaluation, (24hr group n=38 and 48hr group n=17) at 6 weeks evaluation; subjective complaint on surgical incision (24hr group n=104 and 48hr group n=98) at post operation, (24hr group n=56 and 48hr group n=43) at 1 week evaluation, (24hr group n=27 and 48hr group n=13) at 6 weeks evaluation.In conclusion, we found that postoperative removal of the wound dressing at 48 hours has a lower wound score than removal at 24 hours for women with uncomplicated scheduled caesarian delivery.

• 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
• MDR Report Key: 12311055
• MDR Text Key: 266175543
• Report Number: 2210968-2021-07260
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention