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

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Hernia (2240); Post Operative Wound Infection (2446); No Code Available (3191)

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.Citation: j ayub med coll abbottabad.2011; 23(2).[(b)(4).Pdf].

Event Description

It was reported via journal article title: closure of elective abdominal incisions with monofilament, non-absorbable suture material versus polyfilament absorbable suture material.Authors: altaf ahmed talpur, mohammad sharif awan, abdul rasheed surhio.Citation: j ayub med coll abbottabad.2011; 23(2).This prospective, comparative, randomized study was conducted at public and private sector hospitals of nawabshah and hyderabad from 1st jan 2005 to 31st october 2009.The objectives of this study were to assess optimal suture material used for closure of elective abdominal incisions and to see complications associated with these suture materials.A total of 274 patients (117 male and 157 female; age range: 13 to 76 years old) were analyzed for closure of elective abdominal incisions, with 138 patients in group a and 136 patients in group-b.During the surgical procedure in group a, the patient¿s abdominal incision was closed with prolene 1-0 non-absorbable polypropylene sutures.In group b, the abdominal wall was closed with vicryl 1-0 sutures.In group a, reported complications included superficial wound infections (n-8), discharging sinus (n-5), burst abdomen (n-3), and incisional hernia (n-6).In group b, reported complications included superficial wound infections (n-9), discharging sinus (n-1), burst abdomen (n-2), and incisional hernia (n-1).It was concluded that vicryl is an optimal suture material for closure of elective abdominal incisions.Complications are more common with prolene.Properties of suture handling and knot security are also superior with vicryl.

• 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: 7631497
• MDR Text Key: 112157406
• Report Number: 2210968-2018-73705
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/31/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/22/2018
• 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