MAUDE Adverse Event Report: ETHICON INC. PROLENE HERNIA SYSTEM UNKNOWN PRODUCT; MESH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

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.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: ambulatory surgery.2014; 20(3) please see referenced article attached.(b)(4).

Event Description

Journal article title ¿experience in day surgery with prolene hernia system (phs): the aim of this study was to evaluate the outcomes of inguinal hernia repair with prolene hernia system (phs) mesh under local anesthesia with sedation as a day surgery procedure within a surgical training program.The authors presented a retrospective study of 1840 patients (147 women and 1693 men) treated in our ambulatory unit of both primary and recurrent inguinal hernia repair using 3d mesh from 1997 to 2005.During the surgical procedure, phs was used for all repairs.In both direct and indirect hernia repair, the hernia sac was dissected and reduced into the abdominal cavity.A preperitoneal space was then created behind the transversalis fascia for the placement of the deep layer of the phs mesh.A critical step of the phs mesh technique was the fixation of the superficial onlay layer to the pubis by prolene 2-0 suture with a maximum of 4 further sutures fixed at the cardinal points of the inguinal ligament and the conjoined tendon.Care was taken to avoid entrapping nerves in the stitches.Reported complications included pain, hematoma, seroma, and infection (n-6); and chronic pain or hernia recurrence (n-4).It was concluded that inguinal hernia repair using the phs technique under local anesthesia with sedation is feasible on a day case basis with a safe and reliable procedure with low rates of complication, recurrence, and late symptoms in both early and long-term follow-up.

• Brand Name: PROLENE HERNIA SYSTEM UNKNOWN PRODUCT
• Type of Device: MESH
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): J-PAC; 25 centre rd; somersworth NH 03878
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7639653
• MDR Text Key: 112429521
• Report Number: 2210968-2018-73854
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2018
• 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