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

Catalog Number	0115312
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	07/23/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This emdr represents the 3dmax mesh (device #1).An additional supplemental emdr was submitted to represent the composix e/x mesh (device #2).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Per information provided: (b)(6) 2004 ¿ patient was diagnosed with ventral in lower quadrants thereby underwent laparoscopic repair with implant of one 3dmax mesh (device #1) and two synthetic mesh.Per operative notes, ¿in left lower quadrant, hernia was noted around the previously placed mesh.The hernia was reduced and 3dmax mesh (device #1) was placed in left side and sutured.The right lower quadrant hernia was reduced and two synthetic meshes were placed and sutured.¿ (note: the previously placed mesh was unknown).(b)(6) 2009 ¿ patient was diagnosed with incarcerated umbilical hernia with partial bowel obstruction thereby underwent laparoscopic repair with implant of composix e/x mesh (device #2).Per operative notes, ¿incarcerated umbilical hernia with omentum and colon stucked in hernia was noted.Adhesions were reduced and composix e/x mesh (device #2) was placed in the peritoneal cavity and sutured.¿ (b)(6) 2014 - patient was diagnosed with recurrent left inguinal hernia with contracted mesh (device #1) thereby underwent robotic assisted laparoscopic repair with removal of mesh composix e/x (device #1) and partial removal of 3dmax mesh (device #2) and implant of unknown mesh.Per operative notes, ¿the adhesions from previous meshes (device #1 and #2) were taken down.The mesh (device #2) in epigastrium was completely excised.In left groin, the mesh (device #1) was contracted with hernia.The mesh (device #1) was partially removed and defect was closed with sutures; a synthetic mesh was placed.¿ (note: the mesh implanted in this procedure is unknown).

• Brand Name: 3DMAX
• 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: 22684893
• Report Number: 1213643-2025-00706
• Device Sequence Number: 9456184
• Product Code: FTL
• UDI-Device Identifier: 00801741030741
• UDI-Public: (01)00801741030741(10)41DOD005
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

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 Catalogue Number: 0115312
• Device Lot Number: 41DOD005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 61 YR
• Patient Sex: Female