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

Catalog Number	0115310
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2018 - patient was diagnosed with non-recurrent unilateral left inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device 1).Per op notes, "an incisional hernia was observed and reduced from the site of previous inguinal incision.The hernia sac was reduced.A left sided medium 3dmax mesh (device 1) was placed into the preperitoneal space and over the posterior inguinal floor using sutures." on (b)(6) 2018- patient was diagnosed with recurrent left inguinal hernia thereby underwent an open repair with explant of 3dmax (device 1) and implant of bard flat mesh (device 2).Per op notes, "the previous preperitoneal mesh (device 1) was encountered and found to be balled up was removed.The hernia sac was then reduced.A bard flat mesh (device 2) was cut to size and laid over the layer and secured to the pubic tubercle using sutures.".On (b)(6) 2020 - patient was diagnosed with recurrent left inguinal hernia thereby underwent an open repair with removal of mesh (device 2) and implant of 3dmax mesh (device 3).Per op notes, "a left inguinal incision was made.The old mesh (device 2) was removed.A 3dmax mesh (device 3) was placed and secured with sutures.".
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-jul-2014) is considered to be a best estimate.This emdr represents the 3dmax mesh (device 1).An additional supplemental emdr was submitted to represent the bard flat 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.

• 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: 25364463
• Report Number: 1213643-2026-00705
• Device Sequence Number: 10654591
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727(17)190828(10)HUYG0794
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 08/28/2019
• Device Catalogue Number: 0115310
• Device Lot Number: HUYG0794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2014
• 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 Age: 49 YR
• Patient Sex: Female