MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Catalog Number 0115321

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Granuloma (1876); Inflammation (1932)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including granuloma, abdominal pain and inflammation.Imaging results show there is no recurrence of the hernia and the patient is diagnosed with a chronic granuloma related to a ¿small foreign body about 1.8 cm in diameter¿ on the patient¿s right side from prior surgery.It is unclear if this may represent the non davol permanent fixation used previously to fixate the mesh.There is no mention of any reported issue or visualization of the left sided 3dmesh (#2) with the information received.At this time, the patient¿s future clinical course is unknown.Based on the information received, there is no way to determine whether the bard right 3dmax mesh (#1), may have caused or contributed to the patient¿s postoperative complications.Summary will be updated if/when additional information is received.The instructions-for-use supplied with the device lists inflammation as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.

Event Description

Per information provided by the patient's attorney and medical records: on (b)(6) 2012 - a (b)(6)-year-old male patient presented for evaluation of left inguinal hernia, with concerns of right-sided groin pain as well.Physical examination noted an easily reducible left inguinal hernia and a small right inguinal hernia.On (b)(6) 2020 - the patient underwent laparoscopic inguinal hernia repair.Per the operative report details, a sub-umbilical incision was made and the preperitoneal space on the left was accessed and the pubis was identified.¿the hernia defect was easily identified and there was no obvious additional direct hernia defect.Attention was then turned to the right side and, using blunt dissection and a harmonic scalpel as well, a similar procedure was performed to create the preperitoneal space in order to place the mesh (3dmax right #1).The mesh was then passed into the abdominal cavity and oriented appropriately and then tacked into the pubis using non-bard/davol protex (protack) as well as to the anterior abdominal wall.Similar procedure (3dmax left #2) was then performed on the left side.There was a small hole in the peritoneum and prior to finishing the case, this pneumoperitoneum was dissipated.The mesh was then tucked down over the entire inguinal area to avoid any recurrences and we observed this while we were dissipating the pneumopreperitoneum and they laid in place nicely.¿ on (b)(6) 2020 - about 8 years later, the patient had complaints of abdominal pain; a ct abdomen and pelvis was performed with iv contrast which showed ¿within the ventral right paramedian pelvis¿ there is a well circumscribed nodule with a target like appearance.It measures about 1.8 cm in diameter¿ there is an outer soft tissue attenuation density rim surrounding a fat density focus and a central high density nidus.In retrospect this is visible in the perirectal region in the cul-de-sac area on the prior study.I suspect this represents a loose body related to chronic granulomatous response.It may represent walled off adipose or small foreign body granuloma related to the prior surgical procedure.There is no evidence of recurrent inguinal hernia.No inguinal collection is seen.There is no abscess or hematoma and there is no adenopathy.¿ attorney alleges that the chronic granulomatous response was a function of the patient's prior ventral hernia repair procedure; the patient is suffering endless pain, discomfort, is physically bothered and the device is defective.

• Brand Name: 3DMAX
• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 11458913
• MDR Text Key: 239714759
• Report Number: 1213643-2021-01621
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765(17)160828
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Catalogue Number: 0115321
• Device Lot Number: HUVH0550
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2011
• 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 Age: 67 YR
• Patient Weight: 68