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

Catalog Number	0117170
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348)
Date of Event	10/26/2017
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 alleges surgical intervention; 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 light plug (device #2).An additional emdr was submitted to represent the bard/davol bard flat mesh (device #1).The patient's attorney did not make any allegations regarding the implanted bard/davol perfix plug device.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 an unspecified bard/davol bard mesh (device #1) or an unspecified perfix light plug (device #2) or an unspecified bard/davol perfix plug on (b)(6) 2013 or (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against the bard/davol bard mesh (device #1) and the bard/davol perfix light plug (device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol bard mesh (device #1) or an unspecified perfix light plug (device #2) or an unspecified bard/davol perfix plug on (b)(6) 2013 or (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against the bard/davol bard mesh (device #1) and the bard/davol perfix light plug (device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013 ¿ patient was diagnosed with direct right inguinal hernia thereby underwent open repair with the implant of bard preshaped mesh (device #1).Per op notes, ¿a bard preshaped keyhole mesh (device #1) was placed into defect and secured to the pubic tubercle using sutures.¿ (b)(6) 2014 ¿ patient was diagnosed with indirect left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #2).Per op notes, ¿a large sized perfix plug (device #2) was placed into the defect, sewn into position using sutures.An onlay patch was sewn onto the pubic tubercle, the shelving edge of the inguinal ligament, as well as the transversalis fascia.¿ (b)(6) 2017 ¿ patient was diagnosed with recurrent left and primary right inguinal hernia thereby underwent open repair with the implant of perfix plug (device #3) and bard mesh (device #4).Per op notes, ¿on right, the indirect hernia sac was reduced.A small size perfix plug (device #3) was placed in the area and sewn into position using sutures.An onlay patch was sewn on the pubic tubercle, the shelving edge of the inguinal ligament and transversails fascia using sutures.On left, small medial direct hernia defect was identified.A small piece of bard mesh (device #4) was sewn into position using sutures.¿ (note: the mesh implanted on left side of defect in this procedure was unknown).
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 alleges surgical intervention; 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 light plug (device #2).An additional emdr was submitted to represent the bard/davol bard flat mesh (device #1).The patient's attorney did not make any allegations regarding the implanted bard/davol perfix plug device.Should additional information be provided a supplemental emdr will be submitted.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 light plug (device #2).An additional supplemental emdr was submitted to represent the bard/davol 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.

• 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: 8861743
• Report Number: 1213643-2019-06672
• Device Sequence Number: 526032
• Product Code: FTL
• UDI-Device Identifier: 00801741031007
• UDI-Public: (01)00801741031007(17)190628(10)HUYE0211
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 0117170
• Device Lot Number: HUYE0211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 06/19/2025
• 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 Age: 41 YR
• Patient Sex: Male