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

Catalog Number	0117321
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, when opened the sealed edge of the 3dmax light mesh was noted to be splitting.Review of a photo provided shows a 3dmax light mesh laying in an open clamshell tray.There is a crack/tear present in the seal edge of the mesh and continues into the mesh causing the mesh to separate from the seal edge.Photo review does not assist in determining root cause.As reported the sample is being returned for evaluation; however, has not been received.At this time, no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted.Review of manufacturing records was performed and shows the product was manufactured to specification.To date, this is the only reported complaint for 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.
Event or Problem Description
As reported, when the inner packaging of 3dmax light mesh was opened, it was found that there was a gap in the reinforcing edge strip at the lower end of the patch, and the polypropylene had splitting.There was no patient injury.
Event or Problem Description
As reported, when the inner packaging of 3dmax light mesh was opened, it was found that there was a gap in the reinforcing edge strip at the lower end of the patch, and the polypropylene had splitting.There was no patient injury.
Additional Manufacturer Narrative
As reported, when opened the sealed edge of the 3dmax light mesh was noted to be splitting.Review of a photo provided shows a 3dmax light mesh laying in an open clamshell tray.There is a crack/tear present in the seal edge of the mesh and continues into the mesh causing the mesh to separate from the seal edge.Photo review does not assist in determining root cause.As reported the sample is being returned for evaluation; however, has not been received.At this time, no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted.Review of manufacturing records was performed and shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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 there is a tear in the edge seal of the mesh.The tear starts at the seal and continues along the seal edge, separating the seal from the mesh.The mesh has been visibly handled and there are small areas of blood contamination in the area of the mesh tear.A tear of this nature would not be an out of the box condition and can present with forces applied to mesh.Based on the event as reported and sample condition, the likely root cause is forces applied to the mesh during user/device interface.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.

• Brand Name: 3DMAX LIGHT
• 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: 21827324
• Report Number: 1213643-2025-00310
• Device Sequence Number: 21175626
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(17)290428(10)HUJS0289
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: 0117321
• Device Lot Number: HUJS0289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2024
• 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