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

Catalog Number UNKAA030

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Inflammation (1932); Perforation (2001); Obstruction/Occlusion (2422)

Event Date 03/11/2017

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol flat mesh may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.Inflammation is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.The patient's attorney alleges injuries; however, no details have been provided.Information is limited at this time.The exact day of implant is not reported therefore the date of (b)(6) 2007 has been used.Should additional information be provided a supplemental emdr will be submitted.Note: not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2007: the patient underwent an open umbilical hernia repair in which a marlex mesh was implanted in the patient during the procedure.On (b)(6) 2017: the patient underwent an emergency laparotomy, the surgeon noted patient needed to have repair to the small bowel due to obstruction, repair to the mid-ileal due to perforation and peritonitis.Patient still experienced severe abdominal pain and distention.On (b)(6) 2018: the patient was seen by doctor who after examination and evaluation discussed with patient the need for a ventral incisional hernia repair with mesh excision and component separation.The mesh has to be removed.Patient continues to experience complications related to the marlex mesh and he most likely will require additional surgeries to repair the damage from the product.The marlex mesh implanted in patient failed to reasonably perform as intended.The product therefore had to be surgically removed, necessitating further invasive surgery to repair the very issue that the marlex mesh was intended to repair.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, impairment.The patient has been injured and sustained past and future severe pain, suffering, disability, impairment.Due to the alleged defective marlex mesh.

• Brand Name: 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: jan ling ; 100 crossings blvd.; warwick, RI 02886 ; 8015652663
• MDR Report Key: 8245718
• MDR Text Key: 132990162
• Report Number: 1213643-2019-00243
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• 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: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2018
• 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; Disability