MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD SOFT MESH; SURGICAL MESH

Catalog Number 0117016

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Wound Dehiscence (1154); Necrosis (1971)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

As reported, about 17 days post-implant of the bard soft mesh, the patient, with a complicated medical/surgical history, was diagnosed with wound dehiscence which was treated with antibiotics.Approximately 3.5 years post implant, the patient underwent an additional surgery during which the soft mesh was explanted.As reported, the ae has not resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the procedure, however, based on the information provided, no conclusion can be made.This mdr represents the adverse event of wound dehiscence.An additional mdrs were submitted to represent the adverse events of enterocutaneous fistula and mesh infection.Not returned - mesh explanted.

Event Description

Reported per clinical trial (b)(4): (b)(6) 2017 - subject patient underwent an open multiple recurrent incisional midline hernia repair procedure.A bard sort mesh was implanted using sutures.The subject patient was discharged from the hospital on (b)(6)-2017.(b)(6) 2017 ¿ subject patient was diagnosed with wound dehiscence.Drainage noted and prescribed with antibiotics.(b)(6) 2017 ¿ necrosis noted, and staples were removed and started medication (santyl).(b)(6) 2017 ¿ some exposed mesh is noted, and wound vac placed.(b)(6) -2017 ¿ wound of 2.5 cm noted and wound vac stopped.Per the study clinician, the reported adverse event of wound dehiscence has been assessed as severe in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as not recovered.(b)(6) 2020 ¿ subject patient was diagnosed with enterocutaneous fistula.Wound of 4 cm diameter with exposed mesh stained with succus vs.Fecal matter.Undermining circumferentially for 1cm and abdominal binder is used.Patient was prescribed with antibiotics due to skin breakdown.(b)(6) 2020 ¿ subject patient was diagnosed with colocutaneous fistula.Per the study clinician, the reported adverse event of enterocutaneous fistula has been assessed as severe in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovered.(b)(6) 2020 ¿ subject patient was diagnosed with a mesh infection and surgical site infection.The patient underwent removal of infected mesh, repair of the enterocutaneous fistula, small bowel resection and incisional hernia repair.Patient was discharged to home on (b)(6) 2020.Per the study clinician, the reported adverse event of mesh infection has been assessed as severe, definitely related to the study device and definitely related to the index procedure.The outcome for this ae is reported as not recovered.

• Brand Name: BARD SOFT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 14473631
• MDR Text Key: 292721720
• Report Number: 1213643-2022-00287
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Catalogue Number: 0117016
• Device Lot Number: HUBN0020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 84 KG