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

Catalog Number 0118241

Device Problem Defective Device (2588)

Patient Problems Erosion (1750); Pain (1994); Abnormal Vaginal Discharge (2123)

Event Date 06/24/2015

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol dulex device used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.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.Note: 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.Not returned.

Event Description

The following was alleged by the patient's attorney and medical records: on (b)(6) 2007: the patient was diagnosed with stress urinary incontinence, vaginal relaxation, abnormal bleeding, right adnexal mass and underwent a two part procedure which included total abd hysterectomy, bilat salpingo-oophorectomy, an abd sacrocolpopexy with implant of a bard/davol dulex mesh to reduce enterocele and implant of a tension-free vaginal tape using a non bard/davol "gynecare tvt" mesh sling.On (b)(6) 2009: the patient was diagnosed with erosion of vaginal mesh and underwent a partial excision of the vaginal mesh and closure of the vagina.Per operative dictation "2cm area a granulation tissue was noted at the apex of the vagina and was trimmed away.It was noted at that time, there was a 1cm area of "suspension mesh" that was present in the center of this area that had to granulation tissue in it.The mesh (dulex) was grasped, all of which appeared to be retroperitoneal and excised in several small pieces.All visible mesh was removed".The patient is reported to have had persistent vaginal pain and drainage.On (b)(6) 2015: the patient was diagnosed with eroded mesh into vagina and underwent a robotic-assisted laparoscopic removal of the sacrocolpopexy mesh (dulex) followed by vaginaoscopy.Per operative dictation "mesh (dulex) released in its entirety as 1 piece.".

• Brand Name: MESH - DULEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BRIDGER BIOMED, INC. -3031159; 2430 north 7th avenue; bozeman MT 59715
• Manufacturer Contact: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 7591172
• MDR Text Key: 110749348
• Report Number: 1213643-2018-01920
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741011870
• UDI-Public: (01)00801741011870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2008
• Device Catalogue Number: 0118241
• Device Lot Number: 41KNBR17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2003
• 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: 80 YR