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

Catalog Number	0116321
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the edge of the 3dmax mid mesh was cracked.The sample is reported to be available for return, however, has not been received at this time.Based on the information reported and without having the physical sample to evaluate, no conclusions can be made.If/when the sample is returned and evaluation has been completed, a supplemental mdr will be submitted to document the results.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 lot of 1166 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.
Event or Problem Description
As reported, during an inguinal hernia repair procedure, a crack was observed on the edge of the 3dmax mid mesh.The mesh was inserted into the patient but was subsequently removed due to the identified defect.A 12 mm trocar was used during the procedure.It was reported that another 3dmax mid mesh was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, the edge of the 3dmax mid mesh was cracked.The sample is reported to be available for return, however, has not been received at this time.Based on the information reported and without having the physical sample to evaluate, no conclusions can be made.If/when the sample is returned and evaluation has been completed, a supplemental mdr will be submitted to document the results.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 lot of 1166 units released for distribution.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Evaluation of the returned sample finds multiple small cracks in the edge seal of the mesh.The condition of the mesh is consistent with that of a mesh that had been rolled or folded and attempted to be implanted.Based on the sample condition, the likely root cause is the edge seal was inadvertently damaged/ torn during attempted use.No manufacturing anomalies were found.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.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, during an inguinal hernia repair procedure, a crack was observed on the edge of the 3dmax mid mesh.The mesh was inserted into the patient but was subsequently removed due to the identified defect.A 12mm trocar was used during the procedure.It was reported that another 3dmax mid mesh was used to complete the procedure.There was no patient injury.

• Brand Name: 3DMAX MID
• 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: 22798129
• Report Number: 1213643-2025-00758
• Device Sequence Number: 20960388
• Product Code: FTL
• UDI-Device Identifier: 00801741200786
• UDI-Public: (01)00801741200786(11)250120(17)291228(10)HUJZ1389
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0116321
• Device Lot Number: HUJZ1389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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: Other
• Patient Sex: Unknown