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 Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

(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.Citation: surgical endoscopy: (2021) 35:4653¿4660.Https://doi.Org/10.1007/s00464-020-07894-w.

Event Description

Title: are laparoscopic and open ventral hernia repairs truly comparable?: a propensity-matched study in large ventral hernias.The objective of our research was to compare hernia recurrence rates in a matched cohort study comparing laparoscopic ventral hernia repair (lvhr) and open preperitoneal ventral hernia repair (oppvhr)s, matched for hernia defect size and follow-up time.From january 2002 to january 2019, 352 patients underwent open and laparoscopic ventral hernia repairs.During oppvhr, #1 pds was used for fascial closure.(n=?) hernia recurrence.(n=?) wound infection.(n=?) seroma.(n=?) hematoma.(n=?) postoperative pain.(n=?) reoperation rate.(n=?) seromas requiring drainage.In conclusion, laparoscopic and open preperitoneal repair for large ventral hernias have equivalent hernia recurrence rates, postoperative pain, and qol on long-term follow-up.Patients undergoing oppvhr were more likely to be recurrent, complex, require components separation, and more likely to develop postoperative wound complications.

• 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: 15674643
• MDR Text Key: 302435553
• Report Number: 2210968-2022-08793
• 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: 10/26/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 10/26/2022
• 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