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

Catalog Number	0117060
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Pain (1994); Hernia (2240)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided no conclusion can be made.The patient reports during the (b)(6) 2020 revision procedure lysis of adhesions was performed on the right testicle chord to free up the testicle.However, it is unclear what is meant by that as the patient did not indicate mesh adhesions.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence and adhesion formation are listed in the adverse reaction section of the instructions-for-use as possible complications.Should additional information be provided, a supplemental emdr will be submitted.This emdr represents device #1 implanted on the patients right side.An additional emdr was submitted to represent the left sided implant.Sample not returned.
Event or Problem Description
The following is based on information provided via maude event report mw5093145 and additional information provided by the contact.On (b)(6) 2015 the patient underwent open bilateral inguinal hernia repair and was implanted with two bard perfix plug mesh.(device #1 right side, device #2 left side).Two months post implant the patient presented to his doctor with stabbing pains.His doctor told him not to worry and would not see him again.On (b)(6) 2020 the patient underwent a revision procedure on the right side.As reported the perfix plug (device #1) was removed and the recurrent hernia was repaired with a non bard polypropylene mesh device.During this procedure two damaged nerves were removed and lysis of adhesions was performed on the right testicle chord to free up the testicle.As reported the patient will undergo revision surgery on the left side once the hospital starts performing non emergency surgeries again.The left side revision surgery as reported, will include removal of mesh and any damaged nerves and inspection of the spermatic chord to left testicle.As reported the patient continues with pain in the inner thigh area and possible bone damage.
Additional Manufacturer Narrative
Based on the information provided no conclusion can be made.The patient reports during the (b)(6) 2020 revision procedure lysis of adhesions was performed on the right testicle chord to free up the testicle.However, it is unclear what is meant by that as the patient did not indicate mesh adhesions.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence and adhesion formation are listed in the adverse reaction section of the instructions-for-use as possible complications.(b)(6) 2022 addendum: h.11: this supplemental emdr has been submitted to report additional information in the jun2022 maude event report.As initially reported in 2020, the bard perfix light plug was explanted and replaced with an implant of a non-bard mesh as part of the (b)(6) 2020 revision procedure related to a hernia recurrence and adhesion related to the right testicle chord.The (b)(6) 2022 maude event report information indicates that in 2022 both perfix [light] plugs were found to be wrapped around the spermatic cord resulting in the explant of both mesh on (b)(6) 2022 and the removal of both testicles.Based on the previous reported event details, it is probable that the right side intervention and device explant on (b)(6) 2022 was of the non-bard mesh reported to have been implanted in (b)(6) 2020.Based on the limited information provided in the (b)(6) 2022 maude event report, no conclusions can be made as to the perfix light plug implanted on the right side caused or contributed to the 2022 event.This emdr represents bard/davol perfix light plug (device #1) implanted on the patient's right side.An additional emdr was submitted to represent the bard/davol perfix light plug (device #2) on the patient's left side.Should additional information be provided, a supplemental emdr will be submitted.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 is based on information provided via maude event report mw5093145 and additional information provided by the contact.On (b)(6) 2015 the patient underwent open bilateral inguinal hernia repair and was implanted with two bard perfix plug mesh.(device #1 right side, device #2 left side).Two months post implant the patient presented to his doctor with stabbing pains.His doctor told him not to worry and would not see him again.On (b)(6) 2020 the patient underwent a revision procedure on the right side.As reported the perfix plug (device #1) was removed and the recurrent hernia was repaired with a non bard polypropylene mesh device.During this procedure two damaged nerves were removed and lysis of adhesions was performed on the right testicle chord to free up the testicle.As reported the patient will undergo revision surgery on the left side once the hospital starts performing non emergency surgeries again.The left side revision surgery as reported, will include removal of mesh and any damaged nerves and inspection of the spermatic chord to left testicle.As reported the patient continues with pain in the inner thigh area and possible bone damage.Addendum per legal claim: attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol perfix light plug on (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against the perfix light plug.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is alleged that the patient sustained personal injury.It is also alleged that the patient experienced emotional distress and the device was defective.(b)(6) 2022 addendum per maude event report (mw5109657): "i had inguinal hernia surgery to repair the hernia's.From day one i had pain but the surgeon told me to man up.Over a period of years contacting 3 other surgeons, they all said to go to back the doctor who performed the original surgery.I told all 3 of them that the original surgeon refused to help me.After the 5 years i finally found 2 doctors to help me.On both sides the bard perfix [light] plug mesh had wrapped so tightly around the spermatic cord causing extreme pain that when they tried to remove the mesh from the cords, they could not due to risk of damaging cord.The doctors did 4 more surgeries to remove both left and right cords and testicles.They also had to remove all 3 nerves on both sides." ".After i lost both of my testicles because of the bard mesh i am on, testosterone therapy for the rest of my life." the maude event report states the explant date of the perfix [light] mesh devices as (b)(6) 2022.This report represents the bard perfix light plug implanted on (b)(6) 2015 on the right side.

• Brand Name: PERFIX PLUG LIGHT
• 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: 9863311
• Report Number: 1213643-2020-02776
• Device Sequence Number: 14183321
• Product Code: FTL
• UDI-Device Identifier: 00801741030956
• UDI-Public: (01)00801741030956
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 02/28/2020
• Device Catalogue Number: 0117060
• Device Lot Number: HUZB1069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 03/21/2020
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2015
• 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: 59 YR
• Patient Sex: Male