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

Catalog Number 0117311

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

The information provided is limited, and it is unclear what the reporter means by "broken".As reported, the mesh is available for return, however, to date the sample has not been received at davol.Multiple attempts have been made to request additional information, including the return of the sample for evaluation.At this time there has been no response.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 299 units released for distribution in july 2018.Should additional information be obtained and/or the sample returned for evaluation, a supplemental emdr will be submitted.Not returned.

Event Description

As reported,when the surgeon opened the 3dmax light mesh on (b)(6) 2019, he found the mesh was "broken" inside package.The mesh was not used in the case.As reported, the sample is being returned for evaluation.

Manufacturer Narrative

The information provided is limited, and it is unclear what the reporter means by "broken".As reported, the mesh is available for return, however, to date the sample has not been received at davol.Multiple attempts have been made to request additional information, including the return of the sample for evaluation.At this time there has been no response.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 july 2018.Should additional information be obtained and/or the sample returned for evaluation, a supplemental emdr will be submitted.This is an addendum to the initial emdr to document the receipt of the sample for evaluation.The initial evaluation finds for a large tear in the mesh and some fraying/cracked mesh edges.At this time it is unclear what may have caused the condition of the mesh.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.This addendum is to document the final evaluation results: the evaluation, notes the tear is not a clean cut, that would be caused by scissors.The area in question is similar to a tear which can be caused by incorrect handling or incorrect force applied to the mesh.According to investigation performed, the current handling performed during manufacture is not capable of causing a large tear into the mesh.No force is administered during the manufacturing process.Based on assessment performed, the defect could not be replicated or caused by the manufacturing process and or handling during manufacture.Based on the sample evaluation, the condition of the mesh was not manufacturing related.

Event Description

As reported,when the surgeon opened the 3dmax light mesh on (b)(6) 2019, he found the mesh was "broken" inside package.The mesh was not used in the case.As reported, the sample is being returned for evaluation.

Manufacturer Narrative

The information provided is limited, and it is unclear what the reporter means by "broken".As reported, the mesh is available for return, however, to date the sample has not been received at davol.Multiple attempts have been made to request additional information, including the return of the sample for evaluation.At this time there has been no response.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 299 units released for distribution in (b)(6) 2018.Should additional information be obtained and or the sample returned for evaluation, a supplemental emdr will be submitted.H11: this is an addendum to the initial emdr to document the receipt of the sample for evaluation.The initial evaluation finds for a large tear in the mesh and some fraying/cracked mesh edges.At this time it is unclear what may have caused the condition of the mesh.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.Updated fields: b4, d10, g4, g7 h2, h6, h11.Corrected field: b2.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 Description

As reported,when the surgeon opened the 3dmax light mesh on (b)(6) 2019, he found the mesh was "broken" inside package.The mesh was not used in the case.As reported, the sample is being returned for evaluation.

• Brand Name: 3DMAX LIGHT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8753795
• MDR Text Key: 149812620
• Report Number: 1213643-2019-05694
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Catalogue Number: 0117311
• Device Lot Number: HUCT0124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention