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

Model Number 0112760

Device Problems Defective Device (2588); Material Deformation (2976); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Inflammation (1932); Pain (1994); Hernia (2240); Disability (2371); Swelling/ Edema (4577)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information provided, it is alleged "the patient underwent an additional surgery to repair the hernia defect." it is unclear at this time if the hernia defect repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.If additional event and/or evaluation information is obtained, a follow up 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 returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2012 - the patient underwent surgery for repair of an inguinal hernia, a bard davol perfix plug was implanted to repair the hernia defect.On (b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information provided, it is alleged "the patient underwent an additional surgery to repair the hernia defect." it is unclear at this time if the hernia defect repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 2 years 11 months post implant of perfix plug, patient was diagnosed with hernia recurrence, pain, inflammation, mesh deformation, swelling, sores thereby underwent repair with mesh removal.Per op notes, "the mass was a foreign body mesh that had become wadded up into a clump." the adverse reaction section of the instructions-for-use (ifu) list inflammation as a possible complication.This supplemental emdr represents the perfix plug (device #1).An additional emdr was submitted to represent the ventralex mesh (device #2).

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2012 - the patient underwent surgery for repair of an inguinal hernia, a bard davol perfix plug was implanted to repair the hernia defect.(b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2012 - patient was diagnosed with right lower quadrant ventral incisional hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, ¿small fascial defect at the lateral border of the rectus abdominis muscle consistent with a recurrent incisional hernia or possibly a spigelian hernia was noted.A medium perfix plug (device #1) was inserted into the preperitoneal space where it was spread out so that it is overlapping the defect circumferentially.An onlay patch was then placed over the top of the repaired area and sutured.¿ (b)(6) 2015 - patient visited hospital for recurring abdominal pain in the right lower quadrant, swell up and got sore.(b)(6) 2015 - patient was diagnosed with right lower quadrant abdominal wall hernia thereby underwent open repair with the removal of old mesh (device #1).Per operative notes, ¿patient had a palpable mass, and the mass was a foreign body mesh that had become wadded up into a clump.The mesh was excised from its attachments (device #1).The extent of the right lower quadrant abdominal wall hernia was evident and a medium sized ventralex mesh (device #2) was then placed underneath the muscle and fascia with sutures.¿ (b)(6) 2017 - patient visited hospital for right groin pain and felt a bulge happens there causing worsening pain.Attorney alleges that the patient had adhesions, mesh migration, mesh clumping, pain, hernia recurrence and emotional injuries.

• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 7153025
• MDR Text Key: 96003178
• Report Number: 1213643-2017-01134
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 0112760
• Device Catalogue Number: 0112760
• Device Lot Number: HUWI0556
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2012
• 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): Disability; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 84 KG