MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX ST MESH W/ OPS; SURGICAL MESH

Catalog Number	1221015
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the phasix st w/ ops mesh was quickly dipped in saline prior to use.Reportedly, during the laparoscopic hernia repair converted to a planned open procedure on (b)(6) 2025, the surgeon implanted the phasix st w/ ops mesh and fixated it around the perimeter of the mesh.Once fixation was complete, he laparoscopically went to observe the mesh and noticed some of the mesh was bowing so he decided to add a few more fasteners.The surgeon fixated a few and then the physician assistant (pa) fixated a few but when the pa was adding the extra fixation, it was noticed that the sepra barrier was ¿delaminated from the phasix st mesh, about 2 inches of it was hanging freely.¿ the surgeon and pa decided to use a couple more fasteners to reattach the sepra barrier to the mesh and to cover the areas that did not have the sepra barrier with the patient¿s omentum.The surgeon decided to leave the mesh in place as it was well fixated and felt it would have been more problematic if he had removed it and replaced the mesh.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, after fixating the phasix st mesh (w/ops), it was noted that the mesh was bowing as such additional fixation was added.After adding the extra fixation, it was noted that the sepra barrier was separating from the mesh.There was no reported patient injury.The mesh remains implanted as such is unavailable for review.Based on the information provided, and not having a sample to evaluate, no conclusions can be made.Review of manufacturing records 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.

• Brand Name: PHASIX ST MESH W/ OPS
• 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: 21461207
• Report Number: 1213643-2025-00070
• Device Sequence Number: 7986528
• Product Code: OWT
• UDI-Device Identifier: 00801741163203
• UDI-Public: (01)00801741163203(17)250628(10)HUHU1446
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K190185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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 Expiration Date: 06/28/2025
• Device Catalogue Number: 1221015
• Device Lot Number: HUHU1446
• 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: 02/06/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• 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