MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH

Catalog Number 0115321

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

As reported, about 4 months post implant of the 3dmax mesh fixated by the capsure straight device, the patient experienced pain and infection.The patient was prescribed oral antibiotics and is responding well.Based on the information provided to date, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patient¿s reported symptoms.Infection is a known inherent risk of surgery.The warnings section of the instruction for use (ifu) supplied with this device states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." to date, this is the only reported complaint for this manufacturing lot.This mdr represents the bard/davol 3dmax mesh (device #1).An additional mdr was submitted to represent the bard/davol capsure straight (device #2).Should additional information be provided, a supplemental mdr will be submitted.Not returned - remains implanted.

Event Description

It was reported that, during a laparoscopic procedure on (b)(6) 2020, the patient was implanted with a bard/davol 3dmax mesh fixated by a bard/davol capsure straight fixation device.The patient was fine after the surgery.One week post-implant, the patient had complaints of pain and was prescribed analgesics by the surgeon.The patient returned on (b)(6) 2021 with pain and swelling; the surgeon suspected infection which was confirmed by an ultra-sonogram.The patient was prescribed an oral antibiotic augmentin 650mg twice a day and is responding well.As reported, mesh removal may or may not be required based on the patient's response.

• Brand Name: 3DMAX
• 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: 11222253
• MDR Text Key: 241237254
• Report Number: 1213643-2021-20006
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0115321
• Device Lot Number: HUDT2112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• 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: 24 YR