MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 3DMax; Surgical Mesh

Catalog Number	0115320
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Seroma (2069)
Date of Event	07/06/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2013 - patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of perfix plug (device 1).Per op notes, ¿incision was made in the right groin.The cord contents were reduced.The contents of the hernia sac were reduced.The hernia sac was dissected free.There was a small defect in the ring.A perfix plug (device 1) was placed and sutured.A patch was placed in the floor and sutured.¿ (b)(6)2014 - patient was diagnosed with recurrent right sided inguinal hernia and left inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax (device 2 and 3).Per op notes, ¿on the right inguinal region, a recurrent indirect hernia sac was identified and reduced.The old mesh (device 1) was stuck in the hernia sac was dissected.No evidence of direct or femoral hernia.There was preperitoneal fat in the femoral space was reduced.A 3dmax (device 2) was placed and tacked to cooper's ligament.On the left inguinal region, an indirect hernia sac was identified and reduced.A 3dmax (device 3) was placed and tacked to cooper's ligament.¿ (b)(6)2015 ¿ patient had right lower quadrant pain for six months and right groin bulge thereby underwent ct scan.
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 2).An additional supplemental emdr was submitted to represent the perfix plug (device 1).Note, the manufacturing date (15-may-2014) 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 ; +1(800)556-6756
• MDR Report Key: 50449031
• Report Number: 1213643-2026-01104
• Device Sequence Number: 16032227
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(17)190628(10)HUYE1725
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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: 06/28/2019
• Device Catalogue Number: 0115320
• Device Lot Number: HUYE1725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2014
• 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: Other
• Patient Sex: Male
• Patient Weight: 115 LB