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

Catalog Number	0117070
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Pain (1994); Insufficient Information (4580)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol perfix plug light (device #2).Additional emdrs were submitted to represent the bard/davol perfix plug light (device #1) and the two bard soft meshes (device #3 & device #4).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol perfix plug light (x2) and soft mesh (x3) on (b)(6) 2017 (x2) and/or (b)(6) 2017 (x2) and/or (b)(6) 2018.As reported the patient is making a claim for an adverse patient outcome against perfix plug light (x2) and soft mesh (x2).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." it is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol perfix plug light (x2) and soft mesh (x3) on (b)(6) 2017 (x2) and/or (b)(6) 2018.As reported the patient is making a claim for an adverse patient outcome against perfix plug light (x2) and soft mesh (x2).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." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2017 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of two perfix light plugs (device 1 and 2).Per op notes, "two perfix light plugs (device 1 and 2) were placed in the preperitoneal space underlying the floor the inguinal canal using sutures." (b)(6) 2017 - patient was diagnosed with bilateral femoral hernia thereby underwent laparoscopic repair with the implant of two bard soft mesh (device 3 and 4).Per op notes, "noted the bilateral femoral hernias, the left containing a peritoneal fat.The left femoral hernia sac was reduced, placed two bard soft mesh (device 3 and 4) into the preperitoneal space using tacks.Attention the right side of the preperitoneal space, the trocars were removed." (b)(6) 2018 - patient had chronic left groin pain thereby underwent repair with removal of previously placed left inguinal mesh (device 1 and 2), neurectomy and implant of bard soft mesh (device 5).Per op notes, "there was a large piece of mesh in the left groin.Taking the mesh down off the anterior abdominal wall, this was adherent to the epigastric vessels.Identified the retroperitoneal ilioinguinal, iliohypogastric and genitofemoral nerves which were transected.A bard soft mesh (device 5) was placed into the abdominal wall using tacks." (note: the previously placed bard soft mesh (device 3 and 4) were not seen during this procedure).
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; however, no details have been provided.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.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-nov-2016) is considered to be a best estimate.This supplemental emdr represents the bard/davol - perfix light plug (device 2).Additional supplemental emdr's were submitted to represent the bard/davol - perfix light plug (device 1), bard soft mesh (device 3), bard soft mesh (device 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.

• Brand Name: PERFIX PLUG LIGHT
• 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: 12156993
• Report Number: 1213643-2021-05997
• Device Sequence Number: 4763843
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963(17)211128(10)HUAY2083
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 11/28/2021
• Device Catalogue Number: 0117070
• Device Lot Number: HUAY2083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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 Age: 56 YR
• Patient Sex: Female