MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH OVAL; MESH, SURGICAL, POLYMERIC

Catalog Number PHY1015V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hernia (2240); No Code Available (3191)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was received: the patient demographic info: age, gender, weight, bmi at the time of index procedure? unknown.What were current symptoms following the index surgical procedure? onset date? unknown.Other relevant patient history/concomitant medications: unknown.Product lot number? unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? mesh did not incorporate into abdominal wall.Was the hernia repair associated with this event performed on primary or recurrent hernia? recurrent.What was the defect size/type/location of the hernia associated with this event? midline.Was the defect closed in the original operation? no.What is meant by the mesh incorporated into the fat? mesh was incorporated into the omentum mesh size and overlap? 10x15 cm.Was the procedure associated with this event open or laparoscopic? lap.How much time from initial hernia repair to hernia recurrence? 1 year.How was the recurrence diagnosed? omentum in defect.Date of reoperation? (b)(6) 2016.Are there any pictures available? no.What is the patient¿s current status? unknown.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.

Event Description

It was reported that the patient underwent a robotic recurrent incisional hernia procedure on (b)(6) 2015 and mesh was implanted.The surgeon was able to visualize the defect and stated that the mesh was incorporated to the fat and not the abdominal wall.Additional information was requested.

• Brand Name: PHYSIOMESH OVAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): JOHNSON & JOHNSON INTERNATIONAL; leonardo da vincilaan 15; diegem 1831 ; BE 1831
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6198698
• MDR Text Key: 63100760
• Report Number: 2210968-2016-60112
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHY1015V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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