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

Catalog Number	0117321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A definitive cause of the post-op complications cannot be determined.As reported, patient has experienced chronic pain post implant of the 3dmax light mesh.Imaging shows no recurrence of the hernia.Pain is listed as a possible complication in the adverse reaction section of the instructions-for-use, provided with the device.A review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot (b)(4).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
As reported, on (b)(6) 2023 the patient was implanted with a 3dmax light mesh during the repair of a symptomatic right inguinal hernia.Per information provided " introduction of 5 mm trocars subumbilically and suprapubically.Continuation of wide preperitoneal detachment from the iliac spine to cooper's ligament.A direct hernia is observed.Reduction of the peritoneal sac, which is largely separated from the elements of the spermatic cord.Placement a 3dmax (light) mesh large preformed prosthesis in the preperitoneal detachment space interposed between the peritoneum and the deep inguinal orifice.Progressive exsufflation of the pneumoperitoneum, checking for correct prosthetic positioning.Removal of trocars.Umbilical fastening with vicryl 1 x-stitch.Skin fastening with monocryl 3.0 reverse stitches.Steristrips.Exact compress count at end procedure.Negligible blood loss note: heavy coughing extubation." due to complaints of persistent pain on (b)(6) 2024 the patient underwent examination by doctor and an abdomino-pelvic scan which showed no recurrence of the hernia.The patient's current state is reported as, "dull, permanent pain around the prosthesis, painful sitting or lying position, loss of libido, rapid shortness of breath during everyday physical activity (carrying groceries, housework, etc.).".

• Brand Name: 3DMAX LIGHT
• 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: 22133464
• Report Number: 1213643-2025-00426
• Device Sequence Number: 8340214
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(17)280128(10)HUHP1188
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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 Catalogue Number: 0117321
• Device Lot Number: HUHP1188
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2023
• 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: 51 YR
• Patient Sex: Male