MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 3DMax; Surgical Mesh

Catalog Number	0115321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	03/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2014- patient was diagnosed with recurrent left inguinal hernia, right inguinal hernia, recurrent ventral hernia, thereby underwent robotic assisted laparoscopic repair with implant of ventralight st using echo ps (device 1).Per op notes, "the previously placed synthetic mesh was noted on the anterior abdominal wall.Bilateral inguinal hernias were identified.The hernia sac was identified and dissected.A large 3dmax mesh (device 1) was then placed in the preperitoneal space in left inguinal region and was sutured.A large 3dmax mesh (device 2) was then placed into preperitoneal space in right inguinal region and was sutured.A hernia defect in the midline of the anterior abdominal wall was identified, and a ventralight st using echo ps (device 3) was placed in the abdominal region and was sutured." (b)(6) 2017- patient was diagnosed with recurrent small bowel obstruction, recurrent ventral hernia, thereby underwent open repair with explant of ventralight st using echo ps (device 3), implant of synthetic mesh.Per op notes, "an old midline scar was removed.The previous ventral hernia mesh (device 3) was encountered and excised.Adhesiolysis was performed.The hernia through midline incision was identified and a synthetic mesh was placed and sutured." (b)(6) 2018- patient was diagnosed with recurrent bilateral inguinal hernia, thereby underwent robotic assisted laparoscopic repair with implant of synthetic mesh.Per op notes, "anterior abdominal wall adhesions were taken down.Bilateral recurrent direct hernia defects were noted under the inferior lip of both 3dmax meshes (device 1 and 2).The hernias were reduced and pockets were created for the new mesh.A synthetic mesh was then placed on either side to patch the defect and was sutured.".
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-jun-2014) is considered to be a best estimate.This emdr represents the 3dmax mesh (device 2).Additional supplemental emdrs were submitted to represent the 3dmax mesh (device 1) and ventralight st using echo ps (device 3).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.

• 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 ; +1(800)556-6756
• MDR Report Key: 50226234
• Report Number: 1213643-2026-01029
• Device Sequence Number: 10292513
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765(17)190728(10)HUYF1790
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 07/28/2019
• Device Catalogue Number: 0115321
• Device Lot Number: HUYF1790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2014
• 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: Male
• Patient Weight: 185 LB