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

Catalog Number	0117170
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	09/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol perfix light plug (device #2) used to treat the patient.The patient's attorney did allege injuries; however, no details have been provided regarding the nature of the injury.No lot number has been provided therefore a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol perfix light plug (device #2).An additional emdr was submitted to represent the bard/davol bard flat mesh (device #1).Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2011: the patient underwent surgery for implant of an unspecified bard/davol bard flat mesh (device #1) and an unspecified bard/davol perfix light plug (device #2).Ni/ni/ni: the patient had unspecified injuries.The patient is making a claim for an adverse patient outcome against the bard flat mesh (device #1) and perfix light plug (device #2).The patient's attorney 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.".
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol perfix light plug (device #2) used to treat the patient.The patient's attorney did allege injuries; however, no details have been provided regarding the nature of the injury.No lot number has been provided therefore a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 3 years 4 months post implant of perfix light plug, patient was diagnosed with hernia recurrence, pain, mesh migration thereby underwent repair.The instructions-for-use supplied with the device lists hernia recurrence, pain, migration as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-dec-2009) is considered to be a best estimate.This supplemental emdr represents the perfix light plug (device #2).An additional supplemental emdr was submitted to represent the bard flat mesh (device #1).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
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent surgery for implant of an unspecified bard/davol bard flat mesh (device #1) and an unspecified bard/davol perfix light plug (device #2).Ni/ni/ni: the patient had unspecified injuries.The patient is making a claim for an adverse patient outcome against the bard flat mesh (device #1) and perfix light plug (device #2).The patient's attorney 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." addendum per additional information: (b)(6) 2011 - patient was diagnosed with incarcerated recurrent right inguinal hernia with hemorrhagic cyst of the scrotal sac thereby underwent open repair with the implant of bard flat mesh (device #1) and perfix light plug (device #2).Per operative notes, "the hernia sac was opened and reduced.The hemorrhagic cystic hematoma was excised.The sac was excised.A perfix light plug (device #2) was placed into the internal ring and sutured.The perfix light plug onlay patch placed beneath the aponeurosis of external oblique and sutured.A bard flat mesh (device #1) was placed as a overlay and secured to the upper side of aponeurosis." (b)(6) 2016 - patient was diagnosed with symptomatic umbilical hernia and recurrent right inguinal hernia thereby underwent robotic-assisted transabdominal right groin exploration and umbilical repair with unknown patch.Per operative notes, "there appeared to be migration of mesh (device #1 & #2) in the intra-abdominal compartment with attachment of small bowel.The umbilical hernia contents were dissected free from surrounding tissues and were excised.Dense scarring noted and laparoscopic procedure was aborted.The attenuated tissue was excised, an unspecified patch was placed intra-abdominally and secured with sutures." (b)(6) 2016 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with repair of mesh and right orchiectomy.Per operative notes, "the hernia sac was identified, freed and opened.An unspecified onlay mesh, secured to pubic tubercle and sutured." (note: there was no mention/visualization of the previously placed meshes (device #1 & #2) during this procedure) attorney alleges that the patient had adhesions, loss of testicles, mesh migration, pain, scarring, revision surgery and hernia recurrence.

• Brand Name: PERFIX LIGHT PLUG
• Common Device Name: 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: 8108265
• Report Number: 1213643-2018-04188
• Device Sequence Number: 19399882
• Product Code: FTL
• UDI-Device Identifier: 00801741031007
• UDI-Public: (01)00801741031007(17)120428(10)HUTL1612
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 04/28/2012
• Device Catalogue Number: 0117170
• Device Lot Number: HUTL1612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2009
• 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: Required Intervention; Disability
• Patient Age: 68 YR
• Patient Sex: Male