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

Model Number	0126341
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930)
Date of Event	09/14/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided it was reported the patient experienced adhesions, fistula and infection.Adhesions and fistula are listed as known possible adverse reactions in the instructions-for-use.In regards to infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis." a manufacturing review was performed which found that the device provided was manufactured to specification.This file represents dulex mesh (device #1).A second file was created to address the other dulex mesh device implanted in the patient (device #2).With the current information available it is unknown to what extent the dulex mesh devices may have caused or contributed to the patients adverse outcomes.Note: not returned to manufacturer.
Event or Problem Description
Based on a review of medical records: (b)(6) 2008 - the patient underwent an extensive laparoscopic lysis of adhesions with extensive ventral abdominal wall hernia repair using two dulex mesh devices (dulex #1&2).On (b)(6) 2012 - the patient was diagnosed with a nonhealing fistula tract right lower quadrant.The patient underwent a debridement of skin and subcutaneous tissue and muscle.Per the op report, "there was a piece of mesh there, appears to be gore-tex mesh (dulex), it was contiguous so her incisional hernia repair mesh seems to be infected." on (b)(6) 2012 - the patient had an incisional hernia repair, performed laparoscopic with two separate meshes tacked up (dulex #1&2), one to the right lower quadrant and, in fact, it has a chronically draining fistulous tract and also contaminated, the second mesh is in the midline.Per the op report, the patient underwent an "exploratory laparotomy, removal of two incisional hernia meshes (dulex #1&2) along with the multitude of tacks and this was followed by abdominal wall debridement, skin, subcutaneous tissue, and muscle, and this was followed with closure of incisional hernia midline primary." also per op report: "midline incision was opened, carried down to the hernia mesh.The mesh was kind of opened directly with scissors and then we were able to peel all the bowel and intra-abdominal contents off the abdominal side of the mesh.We took out all the tacks of the mesh to the anterior abdominal wall, no spiral tacks.Then we tediously separated the mesh from the anterior abdominal wall going circumferentially with the midline mesh (dulex #1).This midline mesh was actually tacked and has a secondary mesh in the right lower quadrant (dulex #2) tacked to it and there were a lot of inflammatory changes, unhealthy appearing granulation down in the right lower quadrant and we slowly freed the mesh off the abdominal wall, taking down all the tacks, all the stay sutures.Then we were able to remove all the mesh (dulex #1&2).On (b)(6) 2017: patient was subsequently diagnosed with an incisional, possible spigelian hernia.The patient underwent a strattice (lifecell) mesh incisional hernia repair.

• Brand Name: MESH - DULEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8074751
• Report Number: 1213643-2018-04037
• Device Sequence Number: 16709684
• Product Code: FTL
• UDI-Device Identifier: 00801741011917
• UDI-Public: (01)00801741011917
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K003917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2012
• Device Model Number: 0126341
• Device Catalogue Number: 0126341
• Device Lot Number: BRRC7067
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR