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); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
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 surgical intervention; however, no details have been provided.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 perfix light plug (device #1).Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2014 and (b)(6) 2015, the patient underwent surgery for implant of an unspecified bard/davol perfix light plug (device #1 and device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the two perfix light plug (device #1 and device #2).As reported, the attorney alleges product is defective and that the patient experienced emotional distress.
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 surgical intervention; 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-may-2014) is considered to be a best estimate.This supplemental emdr represents the bard/davol perfix plug light (device #2).An additional supplemental emdr was submitted to represent the bard/davol perfix plug light (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
Attorney alleges that on (b)(6) 2014 and (b)(6) 2015, the patient underwent surgery for implant of an unspecified bard/davol perfix light plug (device #1 and device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the two perfix light plug (device #1 and device #2).As reported, the attorney alleges product is defective and that the patient experienced emotional distress.Addendum per additional information provided: (b)(6) 2014 - patient was diagnosed with right direct inguinal hernia thereby underwent open repair with the implant of perfix light plug (device #1).Per op notes, ¿hernia repair was done by placing a perfix light plug (device #1) into the cord and then precut sheet of mesh was placed across inguinal floor and tacked using suture.¿ (b)(6) 2015 - patient was diagnosed with recurrent right inguinal hernia and left inguinal hernia thereby underwent open repair with the implant of perfix light plug (device #2).Per op notes, ¿adhesions were taken down.The mesh (device #1) had moved slightly laterally.Perfix light plug (device #2) was placed into this direct defect and tacked.A precut sheet of mesh was placed over the top of the previous mesh (device #1) and secured using suture.¿.

• 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: 8737331
• Report Number: 1213643-2019-05506
• Device Sequence Number: 2572618
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963(17)190628(10)HUYE1815
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 06/28/2019
• Device Catalogue Number: 0117070
• Device Lot Number: HUYE1815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2014
• 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
• Patient Sex: Male
• Patient Weight: 79 KG