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

Catalog Number	1200015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of phasix st mesh the patient had recurrent obstructed hernia, severe adhesions thereby underwent revision surgery.Intraoperative photo provided finds adhesions, recurrence and likely noted that the mesh fibers have resorbed, and the cast of the mesh is maintained in the integrated tissue.Based on the information provided, no conclusions can be made as to the degree to which the device may have caused or contributed to the post implant complications.Review of manufacturing records was performed and found the device was manufactured to specification.To date, this is the only reported complaint for this lot of (b)(4) units.Hernia recurrence and adhesions are known inherent risks of the surgery/use of the device and are included as possible complications in the adverse reaction section of the instructions for use, supplied with the device.The ifu states, "significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months, indicate loss in mechanical integrity and strength of the mesh.While fiber segments were observed at 18 months, they continued to degrade." note, the date of event (15-oct-2024) considered to be a best estimate.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 a ventral hernia repair with total laparoscopic hysterectomy (tlh), the patient was implanted with phasix st on (b)(6) 2021.It was reported that in (b)(6) 2024 the patient returned with recurrent obstructed hernia, severe adhesions and found that the mesh has not completely absorbed in 37 months.It was also reported that the patient underwent transversus abdominis release (tar) for recurrent obstructed hernia and patient is recovering.

• Brand Name: PHASIX ST MESH
• 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: 20744167
• Report Number: 1213643-2024-00560
• Device Sequence Number: 20927071
• Product Code: OWT
• UDI-Device Identifier: 00801741095290
• UDI-Public: (01)00801741095290(17)221128(10)HUEX0664
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/08/2024

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 Expiration Date: 11/28/2022
• Device Catalogue Number: 1200015
• Device Lot Number: HUEX0664
• 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: 11/05/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2020
• 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: Female