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

Catalog Number 0112780

Device Problems Defective Device (2588); Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Scarring (2061); Disability (2371)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol perfix plug device may have caused or contributed to the reported event.To date no medical records have been provided.The attorney alleges the patient underwent an additional surgery for revision during which the bowel was injured.Another surgery was performed to remove the failed device, scarring and adhesions were noted.There was a ball of previous mesh overlying the tubercle which was cut free.Adhesion is a known inherent risk of surgery and is listed in the instructions-for-use as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.No sample has been returned for evaluation.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2003: the patient underwent right inguinal hernia repair.A bard/davol perfix plug was implanted in patient during this repair.On (b)(6) 2016: the patient underwent revision surgery.During the revision surgery, patient¿s bowel was injured.On (b)(6) 2017: the patient underwent removal of the failed perfix plug.The physician noted that ¿the hernia sac could not be reduced due to the large amount of scarring and previous mesh that was in place.There was a huge amount of adhesions and scarring in this area.So, it was very difficult to identify anatomy.There was a big ball of previous mesh overlying the tubercle.This was cut free.¿ patient continues to experience complications related to the mesh.He will likely require additional surgeries to repair the damage from the mesh product.The mesh had to be surgically removed, necessitating further invasive surgery to repair the very issue that the product was intended to repair, and thus providing no benefit to him.The patient was caused to suffer severe personal injuries, pain and suffering and other damages.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, impairment.

• Brand Name: PERFIX 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: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652659
• MDR Report Key: 7986821
• MDR Text Key: 124462770
• Report Number: 1213643-2018-03640
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2007
• Device Catalogue Number: 0112780
• Device Lot Number: 43JMD410
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2002
• 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 Outcome(s): Required Intervention; Disability