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

Model Number 0112750

Device Problems Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Abdominal Pain (1685); Foreign Body Reaction (1868); Inflammation (1932); Hernia (2240); Disability (2371)

Event Date 12/10/2014

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the post-operative complications experienced by the patient.No sample has been returned for evaluation.Inflammation and allergic reaction are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication.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: it is alleged by the patients attorney that on (b)(6) 2014, the patient underwent surgery for repair of an umbilical hernia and inguinal hernia.As reported, a bard/davol perfix plug, reference number (b)(4), lot number huxj0072 was implanted to repair the inguinal hernia defect.It is alleged that sometime after placement, the device malfunctioned, inter alia, contracting, suffering degradation, and causing an intense foreign body and inflammatory response.It is alleged that as a result of these failures, the patient has suffered severe injuries and required medical care which has consisted of, amongst other things, removal of the defective device on or about (b)(6) 2014.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective perfix plug.

Event Description

The following was reported to davol by the patient's attorney: it is alleged by the patients attorney that on (b)(6) 2014, the patient underwent surgery for repair of an umbilical hernia and inguinal hernia.As reported, a bard/davol perfix plug, reference number (b)(4), lot number huxj0072 was implanted to repair the inguinal hernia defect.It is alleged that sometime after placement, the device malfunctioned, inter alia, contracting, suffering degradation, and causing an intense foreign body and inflammatory response.It is alleged that as a result of these failures, the patient has suffered severe injuries and required medical care which has consisted of, amongst other things, removal of the defective device on or about (b)(6) 2014.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective perfix plug.Addendum per additional information provided: (b)(6) 2014 - patient was diagnosed with symptomatic umbilical hernia and possible inguinal hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device #1), perfix plug (device #2) and ventralex st (device #3).Per operative notes, "umbilical hernia sac was reduced.A ventralight st mesh (device #1) was placed in the abdominal wall into the peritoneal cavity and tacked.The direct inguinal defect on the left was identified and a perfix plug (device #2) was placed into the defect.Some of the peritoneum was placed over the mesh.Another ventralex st (device #3) small circle patch was secured over the defect and tacked the mesh to the abdominal wall and inguinal wall." (b)(6) 2014 - patient with abdominal pain, mild herniation in umbilical area and recurrent left inguinal hernia had laparoscopic-open repair with the implant of ventralight st w/ echo ps (device #4) and perfix plug (device #5) along with the removal of dislodged perfix plug (device #2).Per operative notes, "adhesions involving a portion of mesh were taken down and no recurrent defect was found.There was some protrusion essentially within the mesh (device #1).Rather than take the mesh out, elected to place a ventralight st w/ echo ps (device #4) above the umbilicus and secured to the anterior abdominal wall.Incision was made to the left groin and previously placed mesh (device #2) was then excised from the spermatic cord.A large perfix plug (device #5) was placed through the defect and secured to the rim of the defect, mesh patch was then sutured to the floor of the canal.¿ attorney alleges that the patient had mesh migration, mesh shrinkage, hernia recurrence, adhesions, pain and emotional injuries.It is also alleged that the cremasteric fibers were amputated and a lipomatous mass of the cord was dissected down to the level of the internal ring.

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the post-operative complications experienced by the patient.No sample has been returned for evaluation.Inflammation and allergic reaction are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication.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 provided, there is no change to the initial determination, no conclusion can be made.Per the medical records review, about 8 months post implant of perfix plug, obese patient was diagnosed with abdominal pain, hernia recurrence and mesh migration thereby underwent repair with mesh removal.The instructions-for-use (ifu) supplied with the device identify hernia recurrence as a possible complication.Review of manufacturing records confirms product was manufactured to specification.This supplemental emdr represents perfix plug (device #2).Additional emdr's were submitted to represent ventralight st (device #1) and ventralex st (device #3).Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned.

• 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: 7154784
• MDR Text Key: 96050800
• Report Number: 1213643-2017-01139
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Model Number: 0112750
• Device Catalogue Number: 0112750
• Device Lot Number: HUXJ0072
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2013
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 110 KG