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

Catalog Number	1200710
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the mesh was not hydrated prior to placement.Photos of a laparoscopic procedure were provided; the photos show the mesh intraoperatively saturated with body fluid and is rolled/folded up.Another photo shows cut mesh outside of the body and is saturated with blood/body fluid.It cannot be determined through review of the photos if the st coating has separated from the mesh as reported.Based on the images provided and event as reported root cause is the result of not hydrating the mesh prior to use.It is known that when an st coated mesh that is not hydrated prior to use is introduced into the body portions of the st coating will become hydrated by body fluid resulting in the hydrated coating sticking to the coating that is not hydrated and can cause the issue reported by the user.Review of manufacturing records confirms product was manufactured to specification.Per the instructions-for-use, supplied with the device, ¿phasix st mesh should be hydrated in saline for no more than 1-3 seconds just prior to laparoscopic placement.To protect the resorbable coating during laparoscopic mesh insertion, insert the prosthesis through the trocar using a rigid instrument, such as non-serrated, 5 mm forceps; do not force the prosthesis through trocar.If phasix st mesh is hydrated longer than 3 seconds and/or does not easily deploy down the trocar, replace trocar and retry with the next available larger sized trocar.Not returned.
Event or Problem Description
As reported a phasix st mesh was cut for a procedure, was entered into a completely dry cavity, once in the cavity it came into contact with blood and was moistened with the same blood from the patient and the saline solution that was in the cavity from a previous wash were the only two solutions that were in the cavity.Once the mesh was moistened it completely folded and fixation was impossible.The mesh was removed as the hydrogel came off and the mesh became bent.There was no reported patient injury.

• 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: 16911589
• Report Number: 1213643-2023-00189
• Device Sequence Number: 20337758
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: 07/28/2024
• Device Catalogue Number: 1200710
• Device Lot Number: HUGV1577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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