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

Catalog Number	0117013
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause determination cannot be made.The mesh was able to be used for the repair and is implanted in the patient.Based on the information provided and not having the sample to evaluate, the complaint event is associated with undetermined root cause.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Regarding fixation the instructions-for-use states, "a minimum of a 4 mm bite should be used.Care should be taken to ensure that the mesh is adequately fixated to the abdominal wall.If necessary, additional fasteners and/ or sutures should be used.¿ should additional information be provided, a supplemental emdr will be submitted.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
It was reported that the bard soft mesh tore while the surgeon was attempting to fixate using sutures.As reported that additional sutures were used to complete the repair.There was no injury to the patient reported.

• Brand Name: BARD SOFT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8230779
• Report Number: 1213643-2019-00123
• Device Sequence Number: 1745730
• Product Code: FTL
• UDI-Device Identifier: 00801741030901
• UDI-Public: (01)00801741030901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 02/28/2023
• Device Catalogue Number: 0117013
• Device Lot Number: HUCN1691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1