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

Catalog Number	0115320
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Hernia (2240)
Date of Event	02/20/2020
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-oct-2007) is considered to be a best estimate.This mdr represents the 3dmax mesh (device 1).An additional supplemental emdr was submitted to represent the perfix plug (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.
Event or Problem Description
Per information provided: on (b)(6) 2008 ¿ patient was diagnosed with symptomatic right inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device 1).Per operative notes, ¿in the right inguinal floor the hernia sac was completely dissected free and completely reduced from the cord structures.A piece of medium sized 3dmax mesh (device 1) was placed into the abdomen and secured to the cooper¿s ligament.The peritoneum was reapproximated and secured with sutures.¿ on (b)(6) 2009 ¿ patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of perfix plug mesh (device 2).Per operative notes, ¿in the medial half of the inguinal floor, the prior mesh (device 1) was palpable and appeared pulled away from the pubic tubercle and cooper ligament area and slightly curled with direct defect medially.The defect was circumferentially reduced and small perfix plug (device 2) was placed into the defect and secured with sutures.The wound was irrigated and reapproximated with sutures.¿ on (b)(6) 2020 ¿ patient was diagnosed with right groin pain thereby underwent right groin exploration and neurectomy with partial excision of inguinal meshes (device 1 and 2).Per operative notes, ¿in the right groin, a hard ball solid piece of meshes (device 1 and 2) was encountered just beneath the external oblique.This was dissected free and dense scar tissues adherent to cord structures were lysed.The ilioinguinal nerve involved in the dense meshes (device 1 and 2) were dissected free and neurectomies were performed.Another ball of meshes (device 1 and 2) were excised and fascia was closed and reapproximated 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: 24485035
• Report Number: 1213643-2026-00265
• Device Sequence Number: 5104533
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(17)121128(10)HURJ2215
• 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: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: 11/28/2012
• Device Catalogue Number: 0115320
• Device Lot Number: HURJ2215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2007
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 104 KG