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

Catalog Number 0117060

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2017

Event Type  malfunction  

Manufacturer Narrative

The sample evaluation finds visible contamination (blood stain) and physical manipulation of the device which is expected of a mesh that was used during an attempted implantation.Per the sample evaluation a portion of the mesh plug was torn but still partially attached.Visual examination of the mesh material shows it to be visibly stretched and appears to have been grasped and pulled on.It appears that forces applied during attempted implantation by the user caused a portion of the inner pedal to tear.The problem appears to have presented prior to securing the implant with suture.No manufacturing anomalies were identified and this appears to be a use of device issue.To date there have been no other complaints reported for this manufacturing lot of (b)(4) units released for distribution in january, 2017.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.

Event Description

The following was reported to davol: it was reported that the bard/davol perfix light plug "opened" inadvertently during right inguinal hernia repair surgery and the mesh partially tore off.Another mesh was implanted to complete the case.There was no injury to the patient.

• Brand Name: PERFIX LIGHT PLUG
• 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7060848
• MDR Text Key: 93481005
• Report Number: 1213643-2017-00926
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030956
• UDI-Public: (01)00801741030956
• Combination Product (y/n): N
• PMA/PMN Number: K092032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2017

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: 11/28/2021
• Device Catalogue Number: 0117060
• Device Lot Number: HUAY2692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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