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

Catalog Number	0117322
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Seroma (2069)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, about two months post implant of the 3dmax light mesh the patient was diagnosed with a seroma which cultured positive for infection, and underwent subsequent surgical intervention for mesh removal.Seroma and infection are known inherent risks of surgery.Seroma is identified in the adverse reactions section of the instructions-for-use, supplied with the device, as a possible complication.Regarding infection the warnings section 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.¿ review of manufacturing records finds the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 196 units released for distribution in september, 2021.
Event or Problem Description
As reported, during a bilateral inguinal hernia repair procedure on (b)(6) 2022, two 3dmax light mesh devices were implanted one in the left and one in the right groin region.As reported, about two months post implant the patient reported right sided pain and was diagnosed with a seroma on the right side.A drain was placed and the fluid was cultured which was positive for a staphylococcus infection.On (b)(6) 2022, the patient underwent additional surgery during which the 3dmax light mesh on right side was removed and replaced with phasix mesh.As reported, the explanted mesh was noted to be incorporated and no signs of mesh infection.

• Brand Name: 3DMAX LIGHT
• Common Device Name: 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: 15031234
• Report Number: 1213643-2022-00517
• Device Sequence Number: 20024405
• Product Code: FTL
• UDI-Device Identifier: 00801741031076
• UDI-Public: (01)00801741031076
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2026
• Device Catalogue Number: 0117322
• Device Lot Number: HUFV0688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female