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

Catalog Number	0115310
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/15/2020
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.Note, the manufacturing date (15-may-2016) is considered to be a best estimate.This emdr represents the 3dmax mesh (device 1).An additional supplemental emdr was submitted to represent the 3dmax 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: on (b)(6) 2016 - patient was diagnosed with bilateral inguinal hernia and umbilical hernia thereby underwent laparoscopic repair with implant of two 3dmax meshes (device 1 and 2).Per operative notes, "the hernia sacs in the right and left inguinal area were reduced and spermatic cords were skeletonized.The medium 3dmax mesh (device 1- left) and medium 3dmax mesh (device 2- right) was placed into the pre-peritoneal space and fixed to the cooper¿s ligament and anterior abdominal wall with tacks.The fascia was closed and secured with sutures and tacks.The umbilical hernia in the infraumbilical area was noted.The sac was reduced and resected circumferentially.The fascial defect was closed and secured with sutures." on (b)(6) 2020 - patient was diagnosed with recurrent bilateral inguinal hernia thereby underwent open repair with implant of two perfix plugs (device 3 and 4).Per operative notes, "in the left inguinal area, a large direct hernia and large lipoma of the left cord was noted.The hernia was reduced and cord structures were dissected.A large perfix plug (device 3) was placed along the floor of the inguinal canal and sutured in place with sutures.In right side, the floor of the inguinal canal was intact, a small indirect hernia and small lipoma of cord was noted and removed.A medium sized perfix plug mesh (device 4) was placed over the defect and sutured in place with sutures.The external oblique fascia was closed and secured with sutures.".

• 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: 24894081
• Report Number: 1213643-2026-00517
• Device Sequence Number: 15691375
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727(17)210528(10)HUAS0488
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: 05/28/2021
• Device Catalogue Number: 0115310
• Device Lot Number: HUAS0488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2016
• 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: 67 YR
• Patient Sex: Male