MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX LIGHT; SURGICAL MESH

Catalog Number	0117320
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported the condition of the mesh was alleged to be an out of the box condition.Initial evaluation of the sample finds no contamination on the mesh and there is no visible indication that the device was rolled in preparation for deployment into the patient.The initial evaluation finds two (2) cracks in the edge seal of the mesh.However the cracks did not extent into the mesh; there was no tearing of the mesh.At this time it is unclear what may have caused the condition of the mesh.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in august, 2019.The sample has been sent to the manufacturing facility for further evaluation.When this evaluation has been completed a supplemental emdr will be submitted to document the results.
Event or Problem Description
It was reported that a tear was noted on the top of the 3dmax mesh when opening the package.There was no damage noted to the packaging prior to removing the mesh.No patient involvement.
Event or Problem Description
It was reported that a tear was noted on the top of the 3dmax mesh when opening the package.There was no damage noted to the packaging prior to removing the mesh.No patient involvement.
Additional Manufacturer Narrative
As reported the condition of the mesh was alleged to be an out of the box condition.Initial evaluation of the sample finds no contamination on the mesh and there is no visible indication that the device was rolled in preparation for deployment into the patient.The initial evaluation finds two (2) cracks in the edge seal of the mesh.However the cracks did not extent into the mesh; there was no tearing of the mesh.At this time it is unclear what may have caused the condition of the mesh.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of 682 units released for distribution in august, 2019.The sample has been sent to the manufacturing facility for further evaluation.When this evaluation has been completed a supplemental emdr will be submitted to document the results.Addendum (b)(6) 2020: this is an addendum to the initial emdr to document the results of the sample evaluation performed at the manufacturing facility.The most probable root cause is determined to be a potential manufacturing process and handling event.All appropriate manufacturing personnel have been provided awareness notification.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.

• Brand Name: 3DMAX LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9742210
• Report Number: 1213643-2020-01544
• Device Sequence Number: 1815238
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 0117320
• Device Lot Number: HUDU0156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1