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 Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	12/13/2019
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-sep-2016) is considered to be a best estimate.This mdr represents the 3dmax mesh (device 2).An additional supplemental emdr was submitted to represent the 3dmax mesh (device 1).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) 2016 ¿ patient was diagnosed with bilateral inguinal hernia and incarcerated umbilical hernia thereby underwent laparoscopic repair with implant of two 3dmax meshes (device 1 and 2) and ventralight st mesh (device 3).Per operative notes, ¿ in the right inguinal area, hernia sac was dissected in a posterior fashion and 3dmax mesh (device 1 ¿ right) was placed in preperitoneal space and secured with sutures.In the left side, similarly hernia sac was removed and another 3dmax mesh (device 2-left) was placed and sutured.The incarcerated umbilical hernia was reduced and defect was closed with sutures.A ventralight st mesh (device 3) was placed into the peritoneal cavity and secured transfascially with sutures and tacks.The fascia was closed and secured with sutures.¿ (b)(6) 2019 - patient was diagnosed with right inguinodynia thereby underwent laparoscopic repair with removal of right groin mesh (device 1) and implant of a synthetic and biological mesh.Per operative notes, ¿omental adhesions were removed and almost all mesh (device 1) was removed and small piece of mesh (device 1) on iliac vessels was left insitu.The fascia was closed with sutures and a piece of biological mesh was placed over the cord structures and another synthetic mesh was placed covering the abdominal wall and sutured.¿ (b)(6) 2019 - patient was diagnosed with left inguinodynia thereby underwent robotic assisted laparoscopic repair with removal of mesh (device 2).Per operative notes, ¿omental adhesions were taken down and mesh (device 2) was excised off from the anterior abdominal wall.The peritoneal defect was closed, flaps were raised and fascia was closed 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: 24376494
• Report Number: 1213643-2026-00157
• Device Sequence Number: 5676541
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727(17)210828(10)HUAW0198
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: 08/28/2021
• Device Catalogue Number: 0115310
• Device Lot Number: HUAW0198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2016
• 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: 33 YR
• Patient Sex: Male