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

Catalog Number 0112970

Device Problems Device Issue (2379); Defective Device (2588)

Patient Problems Pain (1994); Hernia (2240); Disability (2371)

Event Date 12/07/2010

Event Type  Injury  

Manufacturer Narrative

To date, limited information has been provided.Based on the information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Hernia recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.If additional information is obtained, a supplemental 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.

Event Description

It is alleged by the patients attorney that on (b)(6) 2010, the patient underwent surgery for repair of an incarcerated left inguinal hernia.As reported, a bard/davol perfix plug, reference number 0112970, lot number huta0663 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2010, the patient underwent an additional surgery to repair recurrent hernia after the perfix plug failed and to remove the perfix plug.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.

Manufacturer Narrative

To date, limited information has been provided.Based on the information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Hernia recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct manufacturing date.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 4 months post implant of perfix plug, patient was diagnosed with hernia recurrence, fibrosis and pain thereby underwent removal of mesh.Review of the manufacturing records was performed and found that the lot was manufactured to specification.Updated fields: a2, a4, b4, b5, b6, b7, d4 (udi no), e3, g1, g3, g6, h2, h6, h10, h11.Corrected field: h4 (manufacturing date) this supplemental emdr represents the perfix plug (device #1).An additional emdr was submitted to represent the perfix plug (device #2).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.

Event Description

It is alleged by the patients attorney that on (b)(6) 2010, the patient underwent surgery for repair of an incarcerated left inguinal hernia.As reported, a bard/davol perfix plug, reference number (b)(4), lot number huta0663 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2010, the patient underwent an additional surgery to repair recurrent hernia after the perfix plug failed and to remove the perfix plug.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) 2010 - patient was diagnosed with incarcerated left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, ¿once all the sac has been pulled up and reduced, the cord is clearly identified.A large plug is placed into the defect and sutured.¿ (b)(6) 2010 - patient presents with pain.(b)(6) 2010 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with removal of perfix plug (device #1) and implant of perfix plug (device #2).Per operative notes, ¿the mesh was palpable and it was dissected free from area which is inferior to the mesh.The mesh was removed with sharp and blunt dissection.Then, a large perfix plug (device #2) was selected and placed into the resulting defect using sutures." (b)(6) 2011 - patient complains of incisional pain and presents with left groin hernia recurrence which contain bulge that goes down towards the pubic tubercle and a little beyond.(b)(6) 2011 - patient was diagnosed with symptomatic recurrent left inguinal hernia thereby underwent laparoscopic repair with the implant of synthetic mesh.Per operative notes, ¿there was no evidence of direct and femoral hernias.A very large and long indirect hernia was identified and the hernia sac was completely reduced and dissected the edge of peritoneum.A piece of synthetic mesh was then tailored, inserted into peritoneal cavity, secured to cooper¿s ligament using tacks." (there was no visualization of perfix plug (device #2)).(b)(6) 2012 - patient was diagnosed with left groin wound infection thereby underwent open repair with removal of infected prolene mesh.Per operative notes, ¿the mesh was deformed and appeared to be consistent with prolene mesh, sutured to the external oblique aponeurosis or inguinal ligament inferiorly and superiorly as well.The mesh was completely dissected free and purulence was found around the mesh." attorney alleges that the patient had pain, hernia recurrence, infection 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: jessica messier ; 100 crossings blvd.; warwick, RI 02886 ; 4018258720
• MDR Report Key: 7268439
• MDR Text Key: 99983843
• Report Number: 1213643-2018-00278
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677
• 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: Attorney
• Type of Report: Initial
• Report Date: 02/13/2018

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: 01/28/2014
• Device Catalogue Number: 0112970
• Device Lot Number: HUTA0663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2009
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 97 KG