MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH; SURGICAL MESH

Catalog Number 0112720

Device Problems Wrinkled (2614); Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Pain (1994); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence is identified in the adverse reaction section of the ifu as a possible complication.Based on the information provided, no surgical intervention has taken place to date.As reported the patient has not had any further imaging performed since 2014.The complainant reports that the patient is currently seeking an md who can further assess the alleged pain and recurrence.At this time, no conclusion can be made.The mesh is alleged to have "wrinkled" and pulled out, it cannot be determined if this was a result of the hernia recurrence or some other cause.The device remains implanted.Should additional information be obtained, a supplemental mdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Device remains implanted.

Event Description

The following was reported via maude event report (mw5067907): " on (b)(6) 2009 surgery for a double inguinal hernia was completed utilizing the bard marlex mesh.Although the patient had mesh placed on the right and left side, only the right side is causing an issue.The first year post surgery, patient experienced right lower quadrant pain where the mesh was placed.He saw a physician twice that year.No test were done.But the physician believed that perhaps the mesh had pulled a muscle.Pain continued and on 2014 a urologist did a catscan that indicated that right lower patch had wrinkled and pulled out causing another hernia post surgery.Patient was told by the urologist that removal of the mesh could cause complications and harm due to device location.Currently patient continues with severe constant pain and uses testosterone injections every 2 weeks, ibuprofen and tylenol daily." the following was reported via follow up with the complainant.Also provided was the implant operative report: based on the implant operative report on (b)(6) 2009, the patient underwent laparoscopic repair of bilateral direct inguinal hernias with the implant of two, bard flat mesh devices.It is reported that in the first year post surgery, the patient experienced right lower quadrant pain where the mesh was placed.There are no issues reported with the left sided repair.The complainant reports following implant the patient visited his surgeon twice and the surgeon performed a physical exam but did not find a recurrent hernia.In 2014 the patient visited a urologist, who then identified the mesh had pulled away from the bottom of the repair and a recurrent hernia was poking through in that area.It is reported that the patient was at work and had a "coughing fit' in which he then felt a strong stinging sensation in the right side and this is when he believes the recurrence occurred.As reported the patient must limit his activity since the repair, due to pain.

• Brand Name: BARD FLAT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6455249
• MDR Text Key: 71576908
• Report Number: 1213643-2017-00202
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561(17)140328(10)HUTC1252
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Catalogue Number: 0112720
• Device Lot Number: HUTC1252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2009
• 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
• Patient Weight: 101