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

Catalog Number 0112780

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This initial mdr is being submitted as a result of a retrospective review of davol¿s mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures.User related.Based on the event description and the sample received (onlay only), it can been determined that the complaint is associated with the onlay portion of the perfix plug.The inner diameter of the onlay was found to be frayed and deformed.The condition of the sample indicates that the mesh was manipulated in such a manner causing the inner diameter of the onlay to become frayed and deformed.The technique guide for the perfix plug and patch state: "secure the tails of the patch loosely around the spermatic cord with 1-2 tacking sutures, then lay the patch on top of the inguinal floor.It is not necessary to suture the onlay patch to the transversalis fascia." as reported that the damage to the device occurred when the doctor went to fix the device with suture.The damage observed to the patch was to the inner diameter not the tails where according to the technique guide securing the patch is recommended.Based on the event as reported, the as received condition and visual evaluation of the onlay, the reported product problem appears to have been attributed by user mishandling.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

It was reported that during an inguinal hernia repair when the doctor wanted to fix the device with suture, the device has frayed.He decided to place another device to finalize the procedure.

• Brand Name: PERFIX PLUG EXTRA LARGE
• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 6727258
• MDR Text Key: 80639833
• Report Number: 1213643-2017-00420
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/19/2017

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 Catalogue Number: 0112780
• Device Lot Number: HUYI2021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2014
• 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
• Patient Age: 52 YR