MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG; SURGICAL MESH

Catalog Number	0112950
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.As report the patient is experiencing pain in the bilateral area however at this time the pain has not been assessed by a medical professional, as such the cause is unknown.Note the date of implant is estimated based on the information provided.Should additional information be provided, a supplemental emdr will be submitted.This emdr represent perfix plug (device 3), additional emdrs were submitted to represent the other bard/davol devices.Remains implanted.
Event or Problem Description
It was reported that in 2007 the patient underwent a right inguinal hernia repair with placement of a perfix plug (device 1).As reported in 2008, the patient underwent an umbilical and left inguinal hernia repair with placement of one perfix plug (device 2) in the umbilical space and two perfix plugs (device 3 and 4) in the left inguinal space.It is reported that the patient developed an infection with drainage from the umbilical hernia repair site (device 2).As reported in 2013 the patient underwent explant of the umbilical mesh (device 2) due to the chronic infection which led to a fistula formation into the colon.During this procedure a bowel resection was performed to remove the fistula.As reported the pathology reports notes inflammation in the area of the explanted mesh (device 2).It is reported that the area has healed well with no signs of infection or recurrent hernia.The contact reports that the patient is experiencing pain in the bilateral inguinal repair sites (device 1, 3, 4) in which he has scheduled a visit with a surgeon to assess the pain.
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.As report the patient is experiencing pain in the bilateral area however at this time the pain has not been assessed by a medical professional, as such the cause is unknown.Note the date of implant is estimated based on the information provided.Addendum: this is an addendum to the initial emdr submitted in 14-may-2019.This supplemental emdr was submitted to report the date of implant provided in the legal form.Should additional information be provided, a supplemental emdr will be submitted.This emdr represent perfix plug (device #3).Additional emdrs were submitted to represent the bard/davol perfix plugs (devices #1, #2 and #4).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.H11: 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.Remains implanted.
Event or Problem Description
It was reported that in 2007 the patient underwent a right inguinal hernia repair with placement of a perfix plug (device 1).As reported in 2008, the patient underwent an umbilical and left inguinal hernia repair with placement of one perfix plug (device 2) in the umbilical space and two perfix plugs (device 3 and 4) in the left inguinal space.It is reported that the patient developed an infection with drainage from the umbilical hernia repair site (device 2).As reported in 2013 the patient underwent explant of the umbilical mesh (device 2) due to the chronic infection which led to a fistula formation into the colon.During this procedure a bowel resection was performed to remove the fistula.As reported the pathology reports notes inflammation in the area of the explanted mesh (device 2).It is reported that the area has healed well with no signs of infection or recurrent hernia.The contact reports that the patient is experiencing pain in the bilateral inguinal repair sites (device 1, 3, 4) in which he has scheduled a visit with a surgeon to assess the pain.Addendum per legal claim: attorney alleges per short form (see attached) that the patient underwent surgery for implant of unspecified bard/davol perfix plugs on (b)(6) 2007 and (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against the perfix plugs.Attorney also alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿ it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.As report the patient is experiencing pain in the bilateral area however at this time the pain has not been assessed by a medical professional, as such the cause is unknown.Note the date of implant is estimated based on the information provided.Addendum #1: this is an addendum to the initial emdr submitted in 14-may-2019.This supplemental emdr was submitted to report the date of implant provided in the legal form.Addendum #2: h11: this supplemental emdr is submitted to document additional information provided and to correct the implant date.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-mar-2008) is considered to be a best estimate.This supplemental emdr represent bard/davol perfix plug (device #4).Additional supplemental emdr's were submitted to represent the bard/davol perfix plug (device #1, #2 & #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.
Event or Problem Description
It was reported that in 2007 the patient underwent a right inguinal hernia repair with placement of a perfix plug (device 1).As reported in 2008, the patient underwent an umbilical and left inguinal hernia repair with placement of one perfix plug (device 2) in the umbilical space and two perfix plugs (device 3 and 4) in the left inguinal space.It is reported that the patient developed an infection with drainage from the umbilical hernia repair site (device 2).As reported in 2013 the patient underwent explant of the umbilical mesh (device 2) due to the chronic infection which led to a fistula formation into the colon.During this procedure a bowel resection was performed to remove the fistula.As reported the pathology reports notes inflammation in the area of the explanted mesh (device 2).It is reported that the area has healed well with no signs of infection or recurrent hernia.The contact reports that the patient is experiencing pain in the bilateral inguinal repair sites (device 1, 3, 4) in which he has scheduled a visit with a surgeon to assess the pain.Addendum per additional information provided: (b)(6) 2007 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per op notes, "a perfix plug (device #1) was placed and sutured." (b)(6) 2008 - patient was diagnosed with umbilical hernia and left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #2) for umbilical hernia and two perfix plug (device #3 & #4) for left inguinal hernia.Per op notes, "in the umbilical defect, a perfix plug (device #2) was placed and sutured.In the left inguinal hernia, two defects identified and perfix plug (device #3 & #4) was placed and sutured." (b)(6) 2013 - patient was diagnosed with infection, recurrent umbilical hernia thereby underwent open repair with removal of infected perfix plug (device #2), resection of two fistulous tracts.Per op notes, "the mesh (device #2) adherent to small bowel and caused bowel erosion resulting in two fistulous tracts was completely removed.".

• Brand Name: PERFIX PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: 8607154
• Report Number: 1213643-2019-03845
• Device Sequence Number: 2340234
• Product Code: FTL
• UDI-Device Identifier: 00801741016653
• UDI-Public: (01)00801741016653(17)130428(10)HUSC0842
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2013
• Device Catalogue Number: 0112950
• Device Lot Number: HUSC0842
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 03/25/2020; 05/06/2025
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 04/03/2020; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Male