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); Abscess (1690)

Event Date 04/25/2022

Event Type  Injury  

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.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 regarding the additional events.Related events captured via 2210968-2022-08558.Citation: british journal of dermatology (2022) 187, pp318¿323 https://doi.Org/10.1111/bjd.21625.

Event Description

Title: interrupted subcuticular suture spacing during linear wound closures and the effect on wound cosmesis: a randomized evaluator-blinded split-wound comparative effectiveness trial.The objective of the study is to determine whether suturing with 1-cm interval subcuticular sutures results in better cosmetic outcomes than suturing with 2-cm interval subcuticular sutures.Between 16 april 2018 and 25 september 2018, 50 patients with postoperative defects of at least 1 cm from either mohs micrographic surgery or a surgical excision with a wound closure of at least 4 cm in length and wound location on the face or neck were included in the study.There were 39 men and 11 women with a mean age of 70.2 years (range 55¿86).Following excision of the skin lesion, the wound was then closed with a single midline buried vertical mattress subcuticular pds ii polydioxanone suture (ethicon).One side of the wound received buried vertical mattress subcuticular sutures spaced 1 cm apart vs.The other side receiving sutures spaced 2 cm apart.After placement of all subcuticular sutures, both sides of the wound were sewn with a single simple running cuticular suture using 5-0 fast absorbing plain gut (ethicon).The reported complications included superficial wound dehiscence (n=3) and suture abscesses (n=17).In conclusion, we found that 1-cm suture spacing was not significantly associated with improved overall cosmetic outcome compared with 2-cm suture spacing when evaluated by blinded observers or the patients themselves.Our results support the use of either interval.

• 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: 15630939
• MDR Text Key: 301980335
• Report Number: 2210968-2022-08557
• 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: Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2022
• 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): Required Intervention