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 Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a hole was noted in the phasix st mesh prior to use.The sample evaluation is currently ongoing.When the sample evaluation is completed, a supplemental mdr will be submitted.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 on (b)(6) 2024, when the phasix st mesh was opened for a robotic inguinal hernia repair case a hole was noted in the mesh material.There was no damage noted to the packaging prior to opening.The mesh was not used in the case.There was no patient injury.
Additional Manufacturer Narrative
As reported, a hole was noted in the phasix st mesh prior to use.The sample evaluation is currently ongoing.When the sample evaluation is completed, a supplemental mdr will be submitted.Addendum: this is an addendum to the initial mdr to document the sample evaluation results.Evaluation of the physical sample finds for the reported condition of the phasix st mesh.Based on the investigation performed and sample evaluation conducted, the issue identified is found to be a manufacturing related condition.Awareness training was provided to the appropriate manufacturing personnel.To date, this is the only reported complaint for this manufacturing lot of 300 units.Review of manufacturing records shows product was manufactured to specification.Updated fields.Corrected field: d4 (udi no.) 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 on (b)(6) 2024, when the phasix st mesh was opened for a robotic inguinal hernia repair case a hole was noted in the mesh material.There was no damage noted to the packaging prior to opening.The mesh was not used in the case.There was no 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: 21178164
• Report Number: 1213643-2025-00008
• Device Sequence Number: 4263226
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337(11)240524(17)270428(10)HUJS1754
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: 1200710
• Device Lot Number: HUJS1754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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