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

Catalog Number	1190400
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the bard/davol phasix flat mesh tore during implant.The subject product was discarded by the user facility and not available for evaluation.Photos of the sample were provided, which show a contaminated phasix flat mesh from the attempted implantation as expected, with sutures still present in the mesh.There is a visible hole/ tear in the center of the mesh.Review of the photo confirms the reported event, however a definitive root cause as to how / why the tear occurred during use cannot be determined.Based on the information available, no conclusion can be made.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september, 2020.
Event or Problem Description
As reported, during an open ventral hernia repair on (b)(6) 2021, the surgeon was suturing a bard/davol phasix flat mesh using a non-bard/davol pds suture at the north and south edges when the mesh tore.As reported, the mesh was removed from the patient and discarded.Another phasix flat mesh was used to complete the case with no further issues.There was no reported patient injury.

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11414800
• Report Number: 1213643-2021-20047
• Device Sequence Number: 3243114
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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: 07/28/2022
• Device Catalogue Number: 1190400
• Device Lot Number: HUEU1422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other