MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH RECTANGULAR; MESH, SURGICAL, POLYMERIC

Catalog Number PHY1515Q

Device Problems Hole In Material (1293); Appropriate Term/Code Not Available (3191)

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

Event Date 03/17/2016

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.Attempt is 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.

Event Description

It was reported that the patient underwent an unknown hernia repair procedure on unknown date and mesh was implanted.Following the procedure, on (b)(6) 2016, the patient underwent a laparoscopic ventral hernia procedure for recurrent ventral hernia.During the second procedure, when the surgeon entered the abdominal cavity, he saw where the hernia had forced its way through the center of the mesh and it split in the middle.The surgeon opined that the fixation of initial mesh was great and held firm and had great tissue integration.The procedure was completed with laying a bard ventral light mesh directly over the top of the existing mesh and fixated as the surgeon saw fit.Additional information has been requested.

• Brand Name: PHYSIOMESH RECTANGULAR
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5724175
• MDR Text Key: 47390877
• Report Number: 2210968-2016-09764
• 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: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHY1515Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• 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