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

Device Problem Insufficient Information (3190)

Patient Problems Seroma (2069); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 06/15/2018.To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.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 ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: international journal of surgery open 3 (2016) 11¿13; doi: http://dx.Doi.Org/10.1016/j.Ijso.2016.04.006.[(b)(4)].

Event Description

It was reported via journal article: "title: shouldice herniorrhaphy ¿ still an effective technique: a retrospective cohort study" author(s): oktay karakose, huseyin eken citation: international journal of surgery open 3 (2016) 11¿13; doi: http://dx.Doi.Org/10.1016/j.Ijso.2016.04.006.This randomized, two-centered, cohort study aimed to evaluate the efficacy of shouldice herniorrhaphy in patients who got the primary inguinal hernia diagnosis, comparing lichtenstein herniorrhaphy.A total of 90 patients (n=67 males and n=23 females; mean age of 38 years [ranging 17-76 years]) with primary inguinal hernia were included which were operated from two different centers using two different techniques: lichtenstein technique (n=48) operated between feb2011 and feb2014, and shouldice technique (n=42) operated between jan2010 and feb2013.In lichtenstein herniorrhaphy, 2/0 prolene sutures were used to fix the polypropylene mesh.In shouldice herniorrhaphy, no.1 prolene sutures were used to stitch the two leaves of the fascia transversalis.Postoperatively, in lichtenstein herniorrhaphy, one patient developed grade 2 wound infection which was treated with drainage and antibiotherapy, and one patient had grade 3a seroma which was treated with aspiration and no additional intervention was felt to be necessary.There were early urinary retention cases on both groups, but this was developed as a complication of the spinal anesthesia.The preferred application technique in primary inguinal hernias was the lichtenstein method.The authors recommended the primary preference of the shouldice method in cases where the use of mesh is not possible and taking it into consideration in surgical training subsequent to the lichtenstein method in hernia repair.

• 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: 7607346
• MDR Text Key: 111310806
• Report Number: 2210968-2018-73515
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2018

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
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/15/2018
• 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