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

Catalog Number 0115321

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Although we anticipate the return of the device for evaluation, at this time the sample has not been received.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 manufacturing lot of (b)(4) units released to production in 03/2013.Based on the available information, and having no sample returned, we are unable to evaluate for root cause or confirm the reported product problem.As reported the problem occurred while placing the mesh in the body with a grasper and this may have presented from device to device interface.If/when the sample is returned and evaluated a supplemental mdr will be submitted.The information provided by bard 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 bard.Not yet returned.

Event Description

The following was reported to davol: it has been reported that during a bilateral tep meshplasty the right sided 3dmax mesh tore while attempting to introduce into the body.As reported the mesh was handled with an atraumatic grasper, folded and inserted using the proper technique.Another 3dmax mesh was used to complete the case without issue.

Manufacturer Narrative

The sample was returned for evaluation.Visual examination of the mesh finds one area to have torn mesh material.The outer sealed edges are in good condition with no damage noted.As reported the problem presented only after the mesh was placed into the body.As such the torn mesh was not an out of box condition.Based on the event as reported and physical condition it appears that the mesh was inadvertently damaged during placement.Root cause appears to be related to user/device interface.

• Brand Name: 3D MAX MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 5116230
• MDR Text Key: 27202972
• Report Number: 1213643-2015-00337
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/09/2015

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 Expiration Date: 03/31/2018
• Device Catalogue Number: 0115321
• Device Lot Number: HUXC0927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1