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

Catalog Number	0115310
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per ansm report no.(b)(4): description of the incident: testicular vein thrombosis chronic groin/testicular pain.Excerpt from the outpatient surgery report - digestive and endocrine surgery department date of procedure: (b)(6) 2023.Left inguinal hernia repair by laparoscopy clinical summary: this is a 30-year-old patient with no particular medical history.I operated on him a little less than a year ago for a right inguinal hernia.A few weeks ago, following weight training, he experienced sharp pain in his left groin.Since then, he has experienced pain whenever he lifts heavy loads.He described minimal pain in the right iliac fossa and above the navel.He performed an ultrasound scan, which revealed a left inguinal hernia with fatty content and a neck measuring approximately 8 mm.There were no abnormalities on the right side.Clinically, a very small left inguinal hernia is palpable and painful on palpation.I do not feel any recurrence on the right side or any abnormalities on the suprapubic linea alba.He has normal bowel movements.There is therefore an indication for outpatient laparoscopic repair of a left inguinal hernia according to tep.He will perform an ultrasound scan of the linea alba.Procedure: under general anesthesia.In the supine position, arms alongside the body.Checking of support points.Lesion observed: left inguinal hernia.Procedure performed: open retro-muscular and pre-peritoneal laparoscopy below the umbilicus with insertion of a 10 mm trocar.Insufflation at 12 mm of mercury.Dissection using retro-muscular optics to create a virtual space up to the pubic arch.Dissection is performed on both sides of the midline.A 5 mm trocar is inserted under visual control at midpoint between the pubis and the umbilicus.Dissection is continued up to the iliac crest.A 5 mm trocar is inserted under visual control at a finger's breadth inside the iliac crest.The dissection is continued downward, preserving the epigastric vessels above and the peritoneal sac below.The hernia sac is completely freed from the cord.The dissection is performed gradually.Careful hemostasis.The deep inguinal orifice is completely freed.Dissection on the right side: no hernia recurrence or particular abnormalities are visible.A medium-sized bard 3dmax mesh is placed under visual control, completely covering the deep inguinal ring with the hernia sac positioned behind the mesh.Deflation under visual control.Removal of trocars.Close the umbilical orifice with an x-shaped vicryl 1 suture on the aponeurosis.Caprosyn 3/0 intradermal suture on the skin.Progress in the ward: the postoperative course is uneventful.Pain is well controlled by the analgesic protocol.The clinical examination is completely reassuring, allowing discharge.Current patient status: chronic groin/testicular pain.Actions taken at the healthcare facility to treat the patient: nr.
Additional Manufacturer Narrative
As reported, the patient had chronic groin/testicular pain and testicular vein thrombosis post implant of 3dmax mesh.Based on the information provided no conclusions can be made.The degree to which the implant used to treat the patient, may be causing, or contributing to the patient¿s postoperative pain and thrombosis is unknown.A review of the manufacturing records show the product was manufactured according to specifications.To date this is the only reported complaint for this lot of (b)(4) units released for distribution.Pain is listed in the adverse reactions section of the instructions-for-use supplied with the device as a possible complication.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 per ansm report no.(b)(4).Description of the incident: testicular vein thrombosis chronic groin/testicular pain.Excerpt from the outpatient surgery report - digestive and endocrine surgery department date of procedure: (b)(4) 2023.Left inguinal hernia repair by laparoscopy clinical summary: this is a 30-year-old patient with no particular medical history.I operated on him a little less than a year ago for a right inguinal hernia.A few weeks ago, following weight training, he experienced sharp pain in his left groin.Since then, he has experienced pain whenever he lifts heavy loads.He described minimal pain in the right iliac fossa and above the navel.He performed an ultrasound scan, which revealed a left inguinal hernia with fatty content and a neck measuring approximately 8 mm.There were no abnormalities on the right side.Clinically, a very small left inguinal hernia is palpable and painful on palpation.I do not feel any recurrence on the right side or any abnormalities on the suprapubic linea alba.He has normal bowel movements.There is therefore an indication for outpatient laparoscopic repair of a left inguinal hernia according to tep.He will perform an ultrasound scan of the linea alba.Procedure: under general anesthesia.In the supine position, arms alongside the body.Checking of support points.Lesion observed: left inguinal hernia.Procedure performed: open retro-muscular and pre-peritoneal laparoscopy below the umbilicus with insertion of a 10 mm trocar.Insufflation at 12 mm of mercury.Dissection using retro-muscular optics to create a virtual space up to the pubic arch.Dissection is performed on both sides of the midline.A 5 mm trocar is inserted under visual control at midpoint between the pubis and the umbilicus.Dissection is continued up to the iliac crest.A 5 mm trocar is inserted under visual control at a finger's breadth inside the iliac crest.The dissection is continued downward, preserving the epigastric vessels above and the peritoneal sac below.The hernia sac is completely freed from the cord.The dissection is performed gradually.Careful hemostasis.The deep inguinal orifice is completely freed.Dissection on the right side: no hernia recurrence or particular abnormalities are visible.A medium-sized bard 3dmax mesh is placed under visual control, completely covering the deep inguinal ring with the hernia sac positioned behind the mesh.Deflation under visual control.Removal of trocars.Close the umbilical orifice with an x-shaped vicryl 1 suture on the aponeurosis.Caprosyn 3/0 intradermal suture on the skin.Progress in the ward: the postoperative course is uneventful.Pain is well controlled by the analgesic protocol.The clinical examination is completely reassuring, allowing discharge.Current patient status: chronic groin/testicular pain.Actions taken at the healthcare facility to treat the patient: nr.
Additional Manufacturer Narrative
As reported, the patient had chronic groin/testicular pain and testicular vein thrombosis post implant of 3dmax mesh.Based on the information provided no conclusions can be made.The degree to which the implant used to treat the patient, may be causing, or contributing to the patient¿s postoperative pain and thrombosis is unknown.A review of the manufacturing records show the product was manufactured according to specifications.To date this is the only reported complaint for this lot of (b)(4) units released for distribution.Pain is listed in the adverse reactions section of the instructions-for-use supplied with the device as a possible complication.Addendum: this is an addendum to the initial mdr submitted to correct the annex f code.Updated fields: b4, g3, g6, h2, h10, h11.Corrected fields: h6 (imdrf annex f grid).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: 24405084
• Report Number: 1213643-2026-00191
• Device Sequence Number: 8269925
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727(17)270828(10)HUGW1178
• 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,Followup
• Report Date (Section B): 02/23/2026

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: 0115310
• Device Lot Number: HUGW1178
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• 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: Male
• Patient Weight: 64 KG