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

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Seroma (2069); 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.If further details are received at the 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: hernia (2013) 17:75¿79.[(b)(4).Pdf].

Event Description

It was reported via journal article title: closure of midline contaminated and recurrent incisional hernias with components separation technique reinforced with plication of the rectus muscles author(s): a.Espinosa-de-los-monteros ¿ i.Domínguez ¿ d.Zamora-valdés ¿ t.Castillo ¿ o.F.Fernández-díaz ¿ h.A.Luna-torres.Citation: hernia (2013) 17:75¿79; doi 10.1007/s10029-012-1012-4.The purpose of this study is to evaluate outcomes regarding large incisional hernia reconstruction with components separation technique using rectus muscle plication as a reinforcement method.Between jan 2007 and dec 2011, 13 patients (n=2 male and n=11 female; average age of 50 years [ranged 16-77 years]) with large midline incisional hernias were treated by closure with components separation technique and reinforcement based on rectus muscle plication.In the procedure, the midline hernia closure was achieved with interrupted no.2 prolene suture in all patients.Complications included wound infection (n=3), seroma (n=3), wound dehiscence (n=1) and hernia recurrence (n=1).One patient with wound infection required reoperation for infection control, while other cases required local wound care on an ambulatory basis.All of these surgical site complications subsided at a mean period of 59 days after the surgery.When use of mesh or biologic materials is not desired, rectus muscle plication is a feasible tool as a reinforcement method after large hernia closure with components separation.

• 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
• MDR Report Key: 7644104
• MDR Text Key: 112548178
• Report Number: 2210968-2018-73907
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 06/06/2018

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: 06/06/2018
• Initial Date FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention