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

Catalog Number PHY1520V

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Hernia (2240); No Code Available (3191)

Event Date 12/09/2016

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.

Event Description

It was reported that the patient underwent a laparoscopic ventral hernia repair procedure on (b)(6) 2016 and the mesh was implanted.Two months after the procedure, the patient returned to the doctor, complaining the hernia had returned.On (b)(6) 2016, a re-operation was performed and it was discovered the mesh pulled away from the fixations and stay sutures and migrated into a ball in the omentum.Other mesh was used to repair the hernia with no patient consequences after the re-operation.No further information is available.

Manufacturer Narrative

Additional information was requested and the following was received: the patient demographic info: age, gender, weight, bmi at the time of index procedure.- i don¿t have this information.What were current symptoms following the index surgical procedure.Onset date.- not sure.Other relevant patient history/concomitant medications.- no.Product lot number.- i don¿t have this information.What is physician¿s opinion as to the etiology of or contributing factors to this event.- he¿s not sure, he has never seen anything like it.Was the hernia repair associated with this event performed on primary or recurrent hernia.- primary.What was the defect size/type/location of the hernia associated with this event.- ventral hernia.Mesh size and overlap.- 6x8 (15x20cm).Was the procedure associated with this event open or laparoscopic.If applicable in what tissue layer did you place the mesh? (onlay, retro-muscular, extra peritoneal or intra abdominal).- laparoscopic.Closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable.- closed the defect with permanent suture.The mesh fixation technique: device and technique.(single or double crown; spacing between implants).- double crown.Was there any triggering event prior to present recurrence? (e.G.Weight gain, sneezing, coughing, strenuous activity).- no.How was the recurrence diagnosed.- patient came back into the office of dr.Saba and once examined, confirmed that the hernia reoccurred.Please provide the results of reoperation.- repaired with bard 6x8 (15x20cm) ventralight st.Mesh location and integrity.- ventral.Was any deficiency or anomaly of the mesh? if yes, please describe it.- physiomesh pulled completely away from the securestraps and waddled up into a ball in the momentum.Are there any pictures available.- none at this time.What is the patient¿s current status.- back to normal activities.

• 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: 6218126
• MDR Text Key: 63722289
• Report Number: 2210968-2017-60001
• 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,Followup
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHY1520V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: No
• 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