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 Codes	Abdominal Pain (1685); Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	06/18/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2013 - patient was diagnosed with bilateral inguinal hernias thereby underwent laparoscopic repair with implant of 3dmax (device 1 and 2).Per op notes, ¿on the right inguinal region, a large direct hernia sac was noted and separated from cord structures and dissected free.The sac was extracted and removed.A 3dmax (device 1) was placed in the peritoneal space and sutured.On the left inguinal region, a direct hernia sac was noted and excised.A 3dmax (device 2) was placed in the peritoneal space and sutured.¿ (b)(6) 2013 - patient was diagnosed with small bowel obstruction and abdominal pain thereby underwent open repair.Per op notes, ¿the peritoneum was opened.A moderate amount of free fluid was drained.Small bowel was extracted.A loop of small bowel had herniated through a small defect in the peritoneum and was adherent to the prior mesh (device 1 and 2) used for the prior hernia repair.The small bowel was freed from the meshes and reduced back into peritoneal cavity.The peritoneal defect was closed 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.Note, the manufacturing date (15-mar-2013) is considered to be a best estimate.This mdr represents the 3dmax (device 2).An additional supplemental emdr was submitted to represent the 3dmax (device 1).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: 24380805
• Report Number: 1213643-2026-00175
• Device Sequence Number: 10519057
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(17)180328(10)HUXC0923
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: 03/28/2018
• Device Catalogue Number: 0115311
• Device Lot Number: HUXC0923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2013
• 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: 57 YR
• Patient Sex: Male