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

Catalog Number 0010103

Device Problems Folded (2630); Detachment of Device or Device Component (2907)

Patient Problems Adhesion(s) (1695); Hernia (2240); Injury (2348)

Event Date 03/19/2015

Event Type  Injury  

Event Description

The following was reported to davol via maude event report (mw 5043138): "had hernia repair 2006 with bard kugel 3"x 3" circle that did not lay down and caused extensive adhesions.Mesh was lifted on the edge, which did not lay down as it was supposed to according to surgeon.I was in severe pain for the past 3 years.I experienced acid and bile back up which caused barrett's esophagus and a sliding hiatal hernia causing extreme pain.I had surgery on 2015 to remove adhesions and abdominal pain stopped and foul taste in mouth stopped immediately.I am still suffering from the hiatal hernia pain and will have surgery in the near future.Also i have bone loss in my jaw from extensive toxins and will be having surgery as soon as hernia surgery is done." per follow up with patient: on (b)(6) 2006 - umbilical hernia repair with the implant of a bard/davol kugel hernia patch.Following implant the patient states that she began to feel discomfort which gradually turned to pain.The patient she was treated for anxiety and gerd.The medications used to treat the anxiety and gerd were not resolving the issues and in 2012 the pain worsened and the patient began to have tremors in her jaw, a foul taste in her mouth and some difficulty breathing.On (b)(6) 2015 - partial explant of the kugel hernia patch, which the patient notes as being "trimmed." the patient reports the surgeon told her the mesh was "curled up/folded" and "did not lay flat." the patient reports that the surgeon also told her when the mesh was initially placed it appeared to not have been flat at that time and this was causing severe adhesions to the small bowel and liver.Due to the adhesions, the patient was reportedly experiencing bile back up into the esophagus which led to the foul taste, deterioration of the jaw bone, the inability to absorb any of the medication she was being treated with orally and eventually she developed a hiatal hernia.The patient reports she will undergo further surgery to "fix her esophagus" and also to correct the jaw bone.

Manufacturer Narrative

The patient reported that the explanting surgeon noted that when the mesh was initially placed it appeared to not have been flat at that time and this was causing severe adhesions to the small bowel and liver.The warning section of the ifu states, "careful attention to suture/staple placement and spacing will help prevent excessive tension or gap formation between the patch and fascial tissue." adhesions is a known and adherent risk to the procedure and is identified in the adverse reaction section of the ifu as a possible complication.Additionally, the patient reported that the mesh was found to be "curled up/folded" and "did not lay flat." the sample was not returned for evaluation, therefore we are unable to review the sample to verify this condition and evaluate for root cause.Based on the information provided, at this time no definitive conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the alleged patient outcome.A review of the manufacturing records shows that the lot was manufactured to specification.If additional information is obtained, a follow up 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.

Manufacturer Narrative

Note: due to a technical issue, the data in the following fields were not transmitted electronically in the previous submission: (b)(4).

• Brand Name: KUGEL PATCH
• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 4965982
• MDR Text Key: 6196923
• Report Number: 1213643-2015-00275
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2010
• Device Catalogue Number: 0010103
• Device Lot Number: 43CPD297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/20/2015
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2005
• 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: 53 YR