MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Burst Container or Vessel (1074)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Not Applicable (3189)

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.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.(b)(4).

Event Description

Title : interrupted abdominal closure prevents burst: randomized.The aim of this double-blinded, three-arm randomized controlled trial was to measure the risk of abdominal wound dehiscence using continuous, interrupted and interrupted far-and-near suturing methods for closure of midline laparotomy and to calculate the relative risk of burst in the aforementioned techniques.A total of 348 patients were included in the study.Continuous closure, 28 males and 93 females with mean age of 37.05, was performed using no.1 prolene suture (polypropylene, johnson & johnson ltd., (b)(4)).Interrupted double-x closure, 21 males and 89 females with mean age of 36.46, was performed using no.1 prolene suture.In the third arm, prof.Hughes far-and-near interrupted method with 33 males and 84 females and mean age of 34.72, the patients were treated by professor hughes modification of smead-jones far-and-near stitch.Twenty-nine (8.33 %) of 348 patients developed burst in the post-operative period.19 (15.70 %) of 121 patients in continuous arm developed burst.Five of 110 (4.55 %) patients in interrupted-x arm and 5 of 117 (4.27 %) patients in modified smead-jones arm developed burst.Surgical site infection (ssi) was present in 57 (16.38 %) of 348 patients.Of these, 21 (36.84 %) developed burst in the post-operative period.Out of the total 114 elective operations performed, 3 (2.63 %) patients developed burst postoperatively.Emergency operations of the 234 emergency surgeries, 26 (11.11 %) patients developed burst.The risk of burst in continuous arm was 19.28 % (16/83) as opposed to 6.94 % (5/67) in interrupted x arm and 6.33 % (5/74) in modified smead-jones arm.Elective operations.The risk of burst in continuous arm was 7.89 % (3/38).No bursts were reported in interrupted x or modified smead-jones arms.In conclusion, intraperitoneal sepsis, cough, uremia, wound infection, and necrosis of linea alba are significant predictors of burst.In presence of these symptoms, the risk of abdominal wound dehiscence can be reduced to less than one-third by using interrupted sutures.Continuous closure gives good results in elective setting.Jaundice, anemia, malnutrition, and intra-abdominal malignancy do not increase the risk of burst.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7634091
• MDR Text Key: 112200894
• Report Number: 2210968-2018-73728
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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?: Yes
• Date Manufacturer Received: 06/04/2018
• 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