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

Catalog Number 0112720

Device Problems Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the patient outcome.As indicated in the article the patient developed a hematoma, which became infected.Postoperative hematoma formation is a known inherent risk of surgery.A direct correlation between the hematoma and the device used to treat the patient is unlikely.As indicated in the article the patient remained free of infection and the hernia repair intact on 9-month follow-up.A lot number was not provided; without a lot number a review of the manufacturing records is not possible.Regarding infection the warning section of the instructions-for-use states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection, however, may require removal of the prosthesis." additionally, the adverse reactions section lists hematoma and extrusion as known possible complications.All bard products are supplied to the customer in a sterile condition.Should additional information be obtained, a supplemental emdr will be submitted.An additional emdr was submitted to document the other case referenced in the article.Not returned.

Event Description

As reported, per journal article: conservative treatment of infected mesh by use of gentamycin impregnated calcium sulphate antibiotic beads: a report of two cases: "a (b)(6) male developed a midline incisional hernia of 7 cm width following a nissen fundoplication.He had no risk factors for mesh infection.An open repair with placement of a 15 cm x 15 cm monofilament polypropylene bard ® (flat) mesh in the retrorectus space was performed.This was complicated by an infected hematoma that spontaneously drained 3 weeks post operatively with complete dehiscence of the skin.At the time, the anterior rectus sheath had dehisced and mesh was visible at the base of the wound.A 3-week course of cefazolin was initiated and an npwt dressing applied.The wound swabbed positive for pan sensitive staphylococcus lugdunesis.On 6-week follow up the mesh was extruded to the level of the skin.The patient remained free of local or systemic symptoms of sepsis but, despite ongoing npwt, wound healing did not progress as expected.At the time, the patient did not wish to undergo mesh explanation.As there was no significant improvement in the wound over the next 6 months, we thought of the possibility of salvaging the mesh with calcium sulphate antibiotic beads (csab) and offered the patient the option of debriding the exposed mesh and attempting to sterilize the remaining mesh with calcium sulphate antibiotic beads (csab).In the operating room, unincorporated mesh was excised, skin flaps and rectus muscle was circumferentially raised, and the incorporated mesh was approximated with interrupted 2-0 polypropylene sutures.Csab, prepared with vancomycin and gentamicin, were placed in the wound over top of the mesh closure, and the skin closed.The wound subsequently dehisced at its inferior aspect on pod#7 and this was managed by homecare nurses with npwt dressing and a 3-week course of cefazolin oral antibiotics.On 3-month follow-up, the wound had achieved complete epithelialization with no evidence of infection or hernia recurrence.The patient remained free of infection and the hernia repair intact on 9-month follow-up.".

• Brand Name: BARD 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 9409322
• MDR Text Key: 170664108
• Report Number: 1213643-2019-11680
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0112720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2019
• 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: 60 YR