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

Catalog Number	0115322
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.The information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was information was reported by the patient attorney.The information included limited patient medical records: per medical records: on (b)(6) 2014 - the patient was diagnosed with right inguinal hernia and underwent a laparoscopic repair with implant of a bard/davol 3dmax mesh.Per the implant operative report details, "preperitoneal space was opened widely and massive indirect sac was encountered.It was carefully dissected free and reduced.The 3dmax mesh was placed across the groin and tacked in place using a non bard/davol tacking device." per attorney for patient: on (b)(6) 2018 - the patient underwent a revision surgery which included explant of the bard/davol 3dmax mesh.
Event or Problem Description
The following was information was reported by the patient attorney.The information included limited patient medical records: per medical records: (b)(6) 2014 - the patient was diagnosed with right inguinal hernia and underwent a laparoscopic repair with implant of a bard/davol 3dmax mesh.Per the implant operative report details, "preperitoneal space was opened widely and massive indirect sac was encountered.It was carefully dissected free and reduced.The 3dmax mesh was placed across the groin and tacked in place using a non-bard/davol tacking device." per attorney for patient: (b)(6) 2018 - the patient underwent a revision surgery which included explant of the bard/davol 3dmax mesh.Addendum per additional information provided: (b)(6) 2014 ¿ patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax mesh.Per op notes, ¿an indirect sac was encountered.The 3dmax mesh was placed across the groin and tacked.¿ (b)(6) 2018 ¿ patient was diagnosed with recurrent right inguinal hernia; incarcerated ventral hernia thereby underwent open repair with the implant of synthetic mesh.Per op notes, ¿recurrent indirect inguinal hernia were dissected away.A synthetic mesh was placed over the floor of inguinal canal and sutured.In mid abdomen, hernia was dissected down and incarcerated fat was reduced.The fascial defect was closed using sutures.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Addendum: h11: this supplemental emdr is submitted to document additional information provided.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.Updated fields: b4, b5, b7, d3, d4 (udi no.), e3, g1, g3, g6, h2, h6, h10, h11.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.H3 other text: not returned.

• 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 ; 4018258495
• MDR Report Key: 7968627
• Report Number: 1213643-2018-03562
• Device Sequence Number: 10813463
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772(17)190328(10)HUYB1663
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 03/28/2019
• Device Catalogue Number: 0115322
• Device Lot Number: HUYB1663
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2014
• 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: Disability; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male