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

Catalog Number	0115321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Pain (1994)
Date of Event	11/18/2021
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.This mdr represents the 3dmax mesh (device 2).An additional supplemental emdr was submitted to represent the ventralight st w/ echo 2 mesh (device 1).An additional emdr was submitted in gcs to represent the 3dmax mesh (device 3).Note, the manufacturing date (15-may-2020) 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.
Event or Problem Description
Per information provided: on (b)(6) 2019: patient was diagnosed with umbilical hernia thereby underwent robotic assisted laparoscopic repair with implant of ventralight st w/ echo 2 mesh (device 1).Per operative notes, ¿an incision was made in the left upper quadrant.The umbilical hernia sac was dissected out.A ventralight st w/ echo 2 mesh (device 1) was placed into the abdominal wall and secured it with sutures.¿ (b)(6) 2020: patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device 2 ¿ right and device 2 ¿ left).Per operative notes, ¿an incision was made into the preperitoneal space infraumbilical midline.Both inguinal hernia sacs were dissected out.Two 3dmax mesh (device 2 ¿ right and device 2 ¿ left) was placed into the right and left inguinal floor and secured it with sutures.¿ (b)(6) 2021: patient was diagnosed with chronic groin pain, right and left ilioinguinal nerve block, adhesion, thereby underwent revision surgery.Per operative notes, ¿an incision was made in the left upper quadrant of the abdomen.There were extensive adhesions of omentum and small bowels to the anterior abdominal wall to the previously placed (device 1) mesh for the ventral hernia repair.All adhesions were taken down.There was right and left inguinal (device 2 and device 3) mesh was identified.They were intact without evidence of any recurrent hernia.The large piece of abdominal wall mesh (device 1) was identified, was implanted on prior umbilical hernia.Bilateral ilioinguinal nerve block was done.The defect was closed with sutures primarily.¿.

• 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: 25304291
• Report Number: 1213643-2026-00681
• Device Sequence Number: 18521082
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765(17)250528(10)HUES0006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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: 05/28/2025
• Device Catalogue Number: 0115321
• Device Lot Number: HUES0006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2020
• 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: 58 YR
• Patient Sex: Male