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

Catalog Number	0117080
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Urinary Retention (2119); Obstruction/Occlusion (2422)
Date of Event	10/18/2020
Type of Reportable Event	Death
Event or Problem Description
Per additional information provided: on (b)(6) 2020 - patient was diagnosed with large intrascrotal right inguinal hernia thereby underwent open repair with the implant of perfix plug light.Per operative notes, ¿hernia was dissected up to the floor of the inguinal canal and then reduced on mass back into the abdomen.An extra-large perfix plug was then placed into the defect and tacked in separate places along conjoined tendon and the shelving edge of the inguinal ligament.The in using the onlay patch an opening was made to accommodate the cord structures and it was placed around the cord.¿ on (b)(6) 2020 - patient was diagnosed with bladder outlet obstruction secondary to bph, acute urinary retention thereby resection of transurethral prostate.Per operative notes, ¿the posterior urethra was noted to have a gross obstruction.¿ attorney alleges that the patient had adhesions, bowel obstruction and perforation, hernia recurrence, fistulae, infection, pain & suffering.It was also alleged that the patient had sepsis, infection, abdominal pain, right groin pain, urinary retention, transurethral resection of the prostate, prostate hypertrophy, urinary tract symptoms, diverticulitis, encephalitis, colon and intestinal ulcers, weight loss and others.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 3 weeks post implant of perfix plug light, patient was diagnosed with obstruction and acute urinary retention thereby underwent hernia repair.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.H3 other text : not returned.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 3 weeks post implant of perfix plug light, patient was diagnosed with obstruction and acute urinary retention thereby underwent hernia repair.Addendum: this is an addendum to the initial emdr submitted (mdr number 1213643-2024-094587).This supplemental emdr is being submitted to report the allegation of patient death.No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including death and subsequent surgical intervention.No autopsy report, or death certificate have been provided.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Updated fields: b2 (outcomes attributed to adv ev), b4, b5, g3, g6, h1, h2, h4 (manufacturing date), h6, h10.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
Per information provided: (b)(6) 2020 - patient was diagnosed with large intrascrotal right inguinal hernia thereby underwent open repair with the implant of perfix plug light.Per operative notes, ¿hernia was dissected up to the floor of the inguinal canal and then reduced on mass back into the abdomen.An extra-large perfix plug was then placed into the defect and tacked in separate places along conjoined tendon and the shelving edge of the inguinal ligament.The in using the onlay patch an opening was made to accommodate the cord structures and it was placed around the cord.¿ (b)(6) 2020 - patient was diagnosed with bladder outlet obstruction secondary to bph, acute urinary retention thereby resection of transurethral prostate.Per operative notes, ¿the posterior urethra was noted to have a gross obstruction.¿ attorney alleges that the patient had adhesions, bowel obstruction and perforation, hernia recurrence, fistulae, infection, pain & suffering.It was also alleged that the patient had sepsis, infection, abdominal pain, right groin pain, urinary retention, transurethral resection of the prostate, prostate hypertrophy, urinary tract symptoms, diverticulitis, encephalitis, colon and intestinal ulcers, weight loss and others.Addendum per legal claim: attorney alleges that the patient underwent surgery for implant of an bard/davol perfix light plug on (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against perfix light plug.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device and wrongful death of the patient.It is also alleged that the patient experienced emotional distress and the device was defective.

• 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: 20118094
• Report Number: 1213643-2024-094587
• Device Sequence Number: 7349926
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970(17)241228(10)HUDZ2045
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 12/28/2024
• Device Catalogue Number: 0117080
• Device Lot Number: HUDZ2045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/02/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2020
• 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: Death; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male