MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT; SURGICAL MESH

Catalog Number 0117311

Device Problems Material Frayed (1262); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

As reported, 3dmax light mesh was found to be frayed and twisted upon opening the package.As reported the subject device is being returned for evaluation.However, at this time has not been received.Based on the available information, we are unable to determine a root cause for the reported event at this time.If/when the sample is received and evaluated, a supplemental mdr will be submitted.

Event Description

As reported, while opening the package of 3dmax light on (b)(6) 2020, the mesh was found to be frayed and twisted.There was no reported patient injury.

Event Description

As reported, while opening the package of 3dmax light on (b)(6) 2020, the mesh was found to be frayed and twisted.There was no reported patient injury.

Manufacturer Narrative

As reported, 3dmax light mesh was found to be frayed and twisted upon opening the package.As reported the subject device is being returned for evaluation.However, at this time has not been received.Based on the available information, we are unable to determine a root cause for the reported event at this time.Addendum: this is an addendum to the initial mdr submitted to document the results of device evaluation.The subject product was returned for evaluation.Visual examination found a crack/tear in the edge seal, and a loose mesh fiber.Also noted in this area was that the mesh was contamination with bodily fluids.It could not be determined, if the tear occurred during the manufacturing process or during handling of the mesh by the end user.Based on the investigation and sample evaluation, the reported event is confirmed; however, a definite root cause cannot be determined at this time.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1019 units released for distribution in february 2020.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.H3 other text : sample evaluated.

• Brand Name: 3DMAX LIGHT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11162821
• MDR Text Key: 226568295
• Report Number: 1213643-2020-20099
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038
• Combination Product (y/n): N
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 0117311
• Device Lot Number: HUEQ1541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 12/24/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other