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

Catalog Number 1190500

Device Problems Torn Material (3024); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

A lot number has not been provided, therefore a review of the manufacturing records could not be conducted.A review of the ifu shows that the surgeon was placing the sutures within the recommended distance from the edge of the device.However, as reported the mesh was placed under tension, it is unclear if this may have contributed to the reported event.As reported the device remains implanted.Without having the sample returned for evaluation we are unable to evaluate for root cause, as such no definitive conclusions can be made at this time.If additional information is obtained, 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.Remains implanted.

Event Description

The following was reported to davol: it is reported that during a "retro muscular mesh placement" procedure, the bard phasix mesh was cut to size and as the surgeon was placing interrupted sutures, the mesh ripped twice.The first time the suture was about 1cm from edge, he realized that was too close to the edge but a few sutures later he placed another suture about 2/3 cm in from the edge and the mesh tore again.As reported, he placed the graft under tension.The mesh was left implanted and it was reported that there was no injury to the patient.

• Brand Name: PHASIX 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: 5676427
• MDR Text Key: 45821783
• Report Number: 1213643-2016-00231
• Device Sequence Number: 1
• Product Code: OOD
• Combination Product (y/n): N
• PMA/PMN Number: K142818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1190500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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