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

Catalog Number 0115311

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Edema (1820); Injury (2348)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

As reported, it is alleged that the patient experienced slight edema post mesh implant.Multiple attempts have been made to obtain additional information.However, 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.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to the specification.If/when additional information is provided, a supplemental emdr will be submitted.Remains implanted.

Event Description

It was reported that post implant of the 3dmax mesh, the patient experienced slight edema due to the fluid accumulation in the body.

• Brand Name: 3DMAX
• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 10341025
• MDR Text Key: 201389484
• Report Number: 1213643-2020-07036
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 0115311
• Device Lot Number: HUDQ1784
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• 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: 53 YR