MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH UNKNOWN PRODUCT; MESH, SURGICAL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); Urinary Retention (2119); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Were the cases discussed in this article previously reported to ethicon? if yes, 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: hernia.2016; 20: 423 428.Doi: 10.1007/s10029-015-1402-5.

Event Description

It was reported via journal article: ¿title: two-port totally extraperitoneal inguinal hernia repair: a 10-year experience¿ authors: m.A.Fuglestad, s.J.Waisbren.Citation: hernia.2016; 20: 423 428.Doi: 10.1007/s10029-015-1402-5.The purpose of this retrospective study was to evaluate the feasibility, safety, and long term outcomes of laparoscopic two-port totally extraperitoneal (tep) inguinal hernia repair.A total of 336 patients (315 male and 21 female; age range: 33 to 61 years old) underwent two-port tep hernia repair.During surgery and following reduction of the hernia sac, a polypropelene flat-sheet mesh and physiomesh was positioned to cover the hernia defect including the direct and indirect spaces.Pneumopreperitoneum was allowed to come down while the mesh was visualized to maintain proper alignment.The 12 mm trocar site was closed with vicryl 0 suture in the fascial layer and skin at both port sites closed with a monocryl 4-0 subcuticular suture.Wounds were then dressed with benzoin and steri-strips.Reported complications included urinary retention (n-5) which was treated with a single dose of 0.4 mg tamsulosin and spontaneous void trial, seroma (n-7), surgical site infection (n-4), hematoma (n-1), chronic inguinal pain (n-3), and hernia recurrence (n-11).It was concluded that the two-port tep appears to be a feasible, safe, and effective method for inguinal hernia repair and should be considered a viable, less invasive alternative to conventional three-port tep hernia repair.

• Brand Name: PHYSIOMESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON GMBH; p.o. box 1409 d22841; norderstedt
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7345823
• MDR Text Key: 102717989
• Report Number: 2210968-2018-71496
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2018

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: 03/06/2018
• Initial Date FDA Received: 03/16/2018
• 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