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	Ambulation or Postural Difficulties (2544); Neuralgia (4413)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per ansm report: (b)(4).As reported, patient underwent laparoscopic repair of right inguinal hernia repair on (b)(6) 2023 during which a 3dmax mesh was implanted.Description of the incident: following the procedure on (b)(6) 2023, the post-operative pain seemed normal for this type of surgery.The pain was quite severe; i could not bear to sit or stand, and i had to remain lying down.My walking range was very limited, and the 15 minutes allowed were impossible to achieve.I began to experience a burning sensation in the perineal region and pain radiating to my lower abdomen and entire right thigh.After the follow-up consultation, i was treated with anti-inflammatories, but as my pain was still present and debilitating, i was put on lyrica and told to be patient, as various ultrasound and mri scans had not revealed anything abnormal.I was off work for several months because i am a physiotherapist and i was unable to resume my work.After three months, despite the pain, i returned to work with a limp and not without difficulty.I told myself that i needed more time or that perhaps a nerve had been damaged during the operation.The pain faded over time, or i got used to it, but it never completely disappeared.Today, i am still limited in certain activities and the groin pain is still more or less present.It increases especially when i am a little more active, and my gait is altered because i am unable to fully extend my hip.Clinical consequences and current condition: today, i regularly experience a burning sensation in the right groin area, pain in the lower abdomen and groin area, while the perineal and thigh pain has disappeared.Certain movements are sometimes difficult when i exercise, and i walk with a limp because i cannot fully extend my leg.Active hip flexion is also painful.My working days are not always easy, as the pain increases if i stand for long periods of time.Adduction and hip flexion are painful, i am limited in all movements that involve these actions.My life has changed as a result of this operation.For a long time, i thought it was me who was having trouble recovering.I did a lot of rehabilitation, but nothing changed, except that we try not to think about it too much and to move forward and get through the day days no matter what, but some days i can't wait to fall asleep so i don't feel the pain anymore.Consult (b)(6) 2024: the patient still reports right inguinal pain of a neuropathic nature.On clinical examination, the scars are clean and non-inflammatory, with no recurrence of the hernia.I am prescribing nsaids and ppis.I will see her again on (b)(6) and extend her sick leave until then.Consult (b)(6) 2024: the patient has recently developed a severe cough and a probable ent infection, with increased pain in the right groin.On clinical examination, i do not initially suspect a recurrence of the hernia, but there is elective pain in the right groin which could indicate either an old haematoma or a small lymph node.Consult (b)(6) 2024: patient is consulting me again today because she is still experiencing alternating phases of no pain and neuropathic pain.Taking nsaids partially relieves her pain.On clinical examination, i find no recurrence of the hernia or any other abdominal abnormalities.I no longer find the small right inguinal lymphadenopathies previously described.Under these circumstances, i am referring the patient back to you to discuss starting treatment with lyrica.I will see the patient again in a month for reassessment." actions taken in the healthcare facility for the patient's care: (b)(6).
Additional Manufacturer Narrative
As alleged, the patient had neuropathic pain and limited walking range, post implant of the 3dmax mesh.Based on the information available to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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: 24522873
• Report Number: 1213643-2026-00291
• Device Sequence Number: 15892553
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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 Catalogue Number: 0115321
• 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
• 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: Disability; Required Intervention
• Patient Sex: Female