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

Catalog Number	0115312
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, about 5-10 years post-implant of an extra-large 3dmax mesh (left), patient developed left sided pain and stiffness due to significant adhesions.It was reported that the surgeon felt both groins, there was significant stiffness and rigidity on the left compared to the right side.As reported, patient underwent robotic procedure on (b)(6) 2023 to remove the mesh completely due to adhesions.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Review of the photo provided shows a 3dmax mesh in vivo with surgical tools in the field.The mesh appears to be consistent with a mesh that has been in vivo for a long period of time with no anomalies noted.Photo review cannot assist in determining root cause for the patient¿s post operative outcome.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Adhesions are a known inherent risk of surgery/use of the device.The adverse reactions section of the instructions-for-use, supplied with the device lists adhesions as possible complication.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.H3 other text : not returned.

• 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: 16939593
• Report Number: 1213643-2023-00193
• Device Sequence Number: 12625367
• Product Code: FTL
• UDI-Device Identifier: 00801741030741
• UDI-Public: (01)00801741030741
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: 0115312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown