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

Catalog Number	0116311
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent laparoscopic inguinal hernia repair with 3dmax mid mesh, during surgery the mesh stuck to itself and got wrapped in a fold of peritoneum.The mesh could not be located laparoscopically, so they had to extend the incision to find it manually using palpation.The mesh was subsequently removed and a new mesh was implanted to complete the procedure.As per the surgeon, "i don't think the issue was a defect with the mesh.The issue is that there is no radio-opaque marker or similar in the mesh that would allow for an alternate means of localization in the event that the mesh is misplaced.For example, when we were trying to find the mesh we considered using a c arm, but there is no way to identify the mesh via x-ray.I don't think the mesh itself caused an issue, but it would be potentially helpful to be able to find it if it migrates or becomes displaced.".
Additional Manufacturer Narrative
As reported, during laparoscopic inguinal hernia repair 3dmax mid mesh stuck to itself and got wrapped in a fold of peritoneum.The mesh was unable to be located using laparoscopy as such to locate the mesh the incision was extended to manually find it using palpation.The mesh was removed and anther used to complete the procedure.Surgeon reports that they don't think the mesh caused the issue.However, no conclusions can be made regarding what may have caused or contributed to the issue that occurred.Review of the manufacturing records showed that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units.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 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: 24966298
• Report Number: 1213643-2026-00549
• Device Sequence Number: 17388073
• Product Code: FTL
• UDI-Device Identifier: 00801741200755
• UDI-Public: (01)00801741200755(11)250529(17)300328(10)HUKR0696
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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: 0116311
• Device Lot Number: HUKR0696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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