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

Catalog Number 0115311

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fever (1858); Unspecified Infection (1930); Weakness (2145)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

As reported, the patient experienced infection post implant of 3dmax mesh, underwent surgery intervention for mesh explant.Based on the information provided to date, no conclusion can be made as to the degree to which the device, may have caused or contributed the patient¿s reported postoperative course.Infection is a known inherent risk of surgery.The warnings section of the instructions-for-use supplied with the 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." a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 662 units released for distribution in june, 2019.This mdr represents the bard/davol 3dmax implanted on the patient¿s left side (device #1).An additional mdr was submitted to represent the bard/davol 3dmax implanted on the patient¿s right side (device #2).Should additional information be provided, a supplemental mdr will be submitted.

Event Description

It was reported that during a laparoscopic procedure on (b)(6) 2020, the patient underwent bilateral implant of two bard/davol 3dmax meshes.It was reported that on (b)(6) 2020, post-implant, patient started having fever, weakness and infection, which was confirmed with mri and sonography.As reported, on (b)(6) 2021, both mesh devices were explanted through a laparoscopic procedure.It was also reported that patient is currently on iv antibiotic piptaz (piperacillin tazobactum).

• 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: 11224379
• MDR Text Key: 228625217
• Report Number: 1213643-2021-20009
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734
• 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: 0115311
• Device Lot Number: HUDS2293
• 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
• Date Device Manufactured: 06/28/2019
• 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: 48 YR