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

Catalog Number	5950008
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Paresthesia (4421)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As per ansm user report (in summary) (b)(4): time of occurrence: 1 month after the procedure.First operation in (b)(6) 2020 to repair an umbilical hernia (suture repair); the operation went well, but 3 months later the pain was still persistent.A clinical examination with the surgeon revealed a new hernia and an eventration.I had another operation in (b)(6) 2020 with the insertion of a mesh (ventralex st mesh).Since then, pain has occurred when walking or exerting myself, accompanied by a burning sensation, though not to the point of incapacitation.I consulted other surgeons for a second opinion; i was advised to wait until after pregnancy before undergoing further surgery.In the meantime, i have been receiving physiotherapy.In (b)(6) 2025, i underwent my third operation for a new umbilical hernia, rectus diastasis and abdominal wall weakness; as a result, a new prosthesis was inserted - the intra-mesh t1 from the cousin surgery group.From the moment i left the recovery room, the pain was excruciating; i was unable to move despite requesting painkillers.I returned home in pain, which has been persistent and debilitating ever since.As per the operating report, on (b)(6) 2020 the patient presented with a symptomatic umbilical hernia and underwent parietal repair surgery with sutures.As per the operating report, on (b)(6) 2020, the patient had a non-reducible and symptomatic sub-umbilical hernia and underwent repair with the implant of ventralex st mesh.No recurrence was observed at the site of the previous umbilical hernia repair.As per the operating report dated (b)(6) 2025: patient previously operated twice several years ago, for umbilical hernia repair and open umbilical hernia repair with placement of a cabsair-type intraperitoneal mesh.Radiological and symptomatic recurrence.Procedure performed: laparoscopic repair of umbilical hernia and placement of a 10 x 15 cm intraperitoneal mesh (ipom) (non-bd/bard mesh).Patient's current condition (following 2020 surgeries): chronic pain, difficulty moving around, prolonged standing or sitting causes pain, sensation of burning, tightness and tingling on a daily basis, difficulty travelling long distances by car.Rest is required.Current condition (following 2025 surgery): my physical and psychological condition has deteriorated due to chronic and debilitating pain, a daily sensation of burning, tingling and tightness.Short, painful nights standing and sitting for long periods of time (approx.30 mins to 1 hour max), followed by rest in a semi-reclined position.
Additional Manufacturer Narrative
As reported, from (b)(6) 2020 - (b)(6) 2025 the patient had undergone the repair of three different umbilical hernias, the second of which the patient was implanted with a bd/bard ventralex st mesh.As reported following each procedure the patient presented with worsening symptoms of pain.Following the third procedure the patient reports the pain had become excruciating, persistent and debilitating.Based on the information provided, no conclusions can be made as to the degree to which the bd/bard implant may have caused or contributed to the patient's postoperative symptoms.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain as a possible complication.A review of manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this lot of (b)(4) units released for distribution.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: VENTRALEX ST
• 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: 25398184
• Report Number: 1213643-2026-00717
• Device Sequence Number: 10706791
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)210528(10)HUDS1173
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 05/28/2021
• Device Catalogue Number: 5950008
• Device Lot Number: HUDS1173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2019
• 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 Sex: Female