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

Catalog Number	0115310
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2009 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of perfix plug (device 1).Per op notes, "incision was made to the left groin, a perfix plug (device 1) was placed to the pubic tubercle." on (b)(6) 2012 - patient was diagnosed with bilateral inguinal hernias and umbilical hernia thereby underwent laparoscopic repair with the removal of mesh (device 1) and implant of two 3dmax mesh (device 2 and 3).Per op notes, "the right side was found to have a direct inguinal hernia that was reduced.Then attention was towards the left side where the previous hernia repair was done.A large mesh plug protruding into the preperitoneal space was found there and was most likely to the pain the patient was experienced.This mesh plug (device 1) was resected.Two 3dmax mesh (device 2 and 3) were placed on both left and right side to the cooper's ligament using tacks.Attention was directed towards the umbilical site that was dissected." on (b)(6) 2018 - patient had chronic groin pain thereby underwent laparoscopy.Per op notes, "the meshes (device 2 and 3) were in place, they appeared to have migrated superiorly slightly but were still in place and no obvious hernias were noted both on right and left side and no other lower inguinal hernias were noted.".
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 mdr represents the 3dmax mesh (device 2).An additional supplemental emdr was submitted to represent the perfix plug (device 1).An additional emdr was created in gcs to represent the 3dmax mesh (device 3).Note, the manufacturing date (15-mar-2012) is considered to be a best estimate.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: 25153535
• Report Number: 1213643-2026-00622
• Device Sequence Number: 16138704
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727(17)170328(10)HUWC0152
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 03/28/2017
• Device Catalogue Number: 0115310
• Device Lot Number: HUWC0152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2012
• 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: 50 YR
• Patient Sex: Male