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

Catalog Number	0115311
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided.(b)(6) 2014 ¿ patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with implant of two 3dmax meshes (device 1 and 2).Per operative notes, ¿in the left side, an indirect inguinal hernia was noted and reduced.A left large 3dmax mesh (device 1) was placed over the defect and secured to the cooper¿s ligament.In the right inguinal area, the defect was reduced and another right large 3dmax mesh (device 2) was placed and tacked to coopers ligament.The fascia was closed and secured with sutures.¿ (b)(6) 2019 - patient was diagnosed with recurrent bilateral direct inguinal hernia thereby underwent open repair with removal of prior meshes (device 1 and 2).Per operative notes, ¿in the right inguinal area, the fascial hernia defect was reduced and closed with sutures.The mesh (device 2) was incised at the inguinal ligament and removed completely.Similarly, in the left inguinal area, the defect was reduced and left inguinal mesh (device 1) was excised and fascia was reapproximated 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.This mdr represents the 3dmax (device 1).An additional supplemental emdr was submitted to represent the 3dmax (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: 24517270
• Report Number: 1213643-2026-00288
• Device Sequence Number: 9723153
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(17)190328(10)HUYC0241
• 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: 2014
• 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): 03/02/2026

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: 0115311
• Device Lot Number: HUYC0241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2014
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 79 KG