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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Post Operative Wound Infection (2446); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article.The device was not returned, therefore an analysis investigation could not be performed.The lot/batch was not provided, therefore the manufacturing records could not be reviewed.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported in a journal article entitled: no-mesh inguinal hernia repair with continuous absorbable sutures: a dream or reality? (a study of 229 patients) authors: mohan p.Desarda citation: the saudi journal of gastroenterology.2008; 14(3): 122 27.Inguinal hernia repair is one of the most common surgical procedures performed worldwide.This study reports the author¿s experience with a new method of inguinal hernia repair with continuous absorbable sutures in 229 male patients (age range: 18 to 93 years old) having 256 hernias.The upper leaf of the external oblique aponeurosis (eoa) is sutured with the inguinal ligament from the pubic tubercle to the abdominal ring using pds ii 1-0 continuous sutures.The first two sutures were taken through the anterior rectus sheath and the last suture is taken so as to narrow the abdominal ring sufficiently.The medial insertion and lateral continuation of this strip is kept intact.The upper free border of the strip is now sutured to the internal oblique with pds ii 1-0 continuous sutures all along its length.This will result in the strip of the eoa being placed behind the cord to form a new posterior wall of the inguinal canal.The spermatic cord is placed in the inguinal canal and the lateral leaf of the eoa is sutured to the newly formed medial leaf of the eoa in front of the cord with pds ii 1-0 continuous sutures.Reported complications include transient wound edema (n-2) which subsided on its own and superficial wound infection (n-2) in which 1 patient was treated with antibiotics and 1 patient required drainage of pus.It was concluded that the new repair technique using continuous absorbable sutures does not use any foreign body and has minimal complications with no recurrence of hernia or chronic groin pain.

• Brand Name: PDS II POLYDIOXANONE SUTURE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7404015
• MDR Text Key: 104677812
• Report Number: 2210968-2018-71985
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2018
• 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