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

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Hematoma (1884); Swelling (2091); Urinary Retention (2119); Post Operative Wound Infection (2446); Blood Loss (2597)

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.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if known, please provide a complaint reference number.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: the american journal of surgery.2016; 211: 24 30.Doi: http://dx.Doi.Org/10.1016/j.Amjsurg.2015.04.019.(b)(4).

Event Description

It was reported via journal article: ¿title: inguinal hernia repair with parietex progrip mesh causes minimal discomfort and allows early return to normal activities¿ authors: pikli batabyal, m.B.B.S.; richard l.Haddad, f.R.A.C.S.; jaswinder s.Samra, d.Phil., f.R.C.S., f.R.A.C.S.; simon wickins, m.B.B.S.; edmund sweeney, f.A.N.Z.C.A.; thomas j.Hugh, m.D., f.R.A.C.S.Citation: the american journal of surgery.2016; 211: 24 30.Doi: http://dx.Doi.Org/10.1016/j.Amjsurg.2015.04.019.The type of inguinal hernia repair used depends on many factors but predominantly the surgeon¿s training, interpretation of the literature, and personal preference.This prospective cohort study describes a consecutive series of open mesh inguinal hernia repairs (modified lichtenstein technique) performed as an outpatient procedure using 2 different mesh types.A total of 540 patients underwent inguinal hernia repair.Primary hernia repairs were performed in 92% of the patients while the remaining 8% underwent repair of the recurrent hernia.During the surgical procedure, polypropylene mesh was fixed with polypropylene 2-0 permanent sutures (ethicon) in 299 patients and parietex progrip mesh was fixed with polydioxanone 2-0 absorbable sutures (ethicon) in 241 patients.Reported complications included cellulitis/wound infection (2.6%), spermatic cord hematoma (1.9%), urinary retention (.6%), epididymitis (.4%), scrotal swelling (.2%), per rectal bleeding (.2%), and hydrocele (.2%).It was concluded that an open anterior inlay mesh repair is safe and results in minimal postoperative pain and early return to normal activities.Progrip mesh resulted in a shorter operative time and more rapid return to normal activities compared with polypropylene mesh.

Manufacturer Narrative

Corrected information: additional information received that indicates this event does not meet reporting serious injury criteria.

Manufacturer Narrative

Additional information.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• 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: 7394067
• MDR Text Key: 104257539
• Report Number: 2210968-2018-71857
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2018

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?: No
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 03/15/2018; 04/06/2018
• Supplement Dates FDA Received: 04/04/2018; 04/16/2018
• 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