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

Catalog Number 0112760

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Itching Sensation (1943); Reaction (2414)

Event Date 09/15/2019

Event Type  Injury  

Manufacturer Narrative

Based on the information currently available we are unable to determine a correlation between the reported reaction and the perfix plug used to treat the patient.A sample will be provided to the patient's allergist for reactivity testing.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, as a specific date was not provided, the date of event was considered as a best estimate ((b)(6) 2019).When/if the result of the reactivity testing are provided, a supplemental emdr will be submitted to document the results provided.Not returned - remains implanted.

Event Description

As reported, on (b)(6) 2019, the patient underwent a right inguinal hernia repair and had a bard/davol medium perfix plug implanted.As reported, about 2 months post implant in (b)(6) 2019, the patient had intermittent itching on head, chest, back, shoulders and arms.The patient had different allergists assess the reported symptoms who at that time performed some testing and determined that the patient had sensitivities to propylene glycol.As reported, the patient was prescribed an allergy medication and since then it is reported that the patient experiences the same issues (itching on head, chest, back and arms).The patient has consulted with a new allergist in (b)(6) 2020 and (b)(6) 2020 who would like to perform a reactivity patch test with a sample of the perfix plug.

Event Description

As reported, on 16-jul-2019, the patient underwent a right inguinal hernia repair and had a bard/davol medium perfix plug implanted.As reported, about 2 months post implant in (b)(6) 2019, the patient had intermittent itching on head, chest, back, shoulders and arms.The patient had different allergists assess the reported symptoms who at that time performed some testing and determined that the patient had sensitivities to propylene glycol.As reported, the patient was prescribed an allergy medication and since then it is reported that the patient experiences the same issues (itching on head, chest, back and arms).The patient has consulted with a new allergist in (b)(6) 2020 and (b)(6) 2020 who would like to perform a reactivity patch test with a sample of the perfix plug.Addendum per allergist office notes: on (b)(6) 2021, the patient had a 96 hour follow up office exam after the perfix plug patch testing was performed on (b)(6) 2021.Per the assessment and plan notes, "allergic contact dermatitis: atopic dermatitis (ezcema).Mildly positive (+1) to medium monofilament knitted polypropylene (perfix plug).This is not convincing evidence that the mesh is causing systemic issues although it should be considered.Recommends repeat skin biopsy with dermatology, consider removing hernia mesh but benefits of this potentially invasive procedure do not outweigh risk and consider starting dupixent biologic injectable for chronic eczema.".

Manufacturer Narrative

Based on the information currently available we are unable to determine a correlation between the reported reaction and the perfix plug used to treat the patient.A sample will be provided to the patient's allergist for reactivity testing.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, as a specific date was not provided, the date of event was considered as a best estimate ((b)(6) 2019).Addendum: this supplemental mdr is submitted to report the results of the reactivity testing.As reported, the patient experienced a ¿mildly positive (+1) reaction to the mesh sample.Based on the test results, it is confirmed that the patient is mildly reactive to the perfix plug.However, the doctor states ¿this is not convincing evidence that the mesh is causing systemic issues although it should be considered.¿ updated fields: a2, a3, a4, b4, b5 (event description), b6 (relevant tests/laboratory data), b7, g4, g7, h2, h6, h10.If/when additional information is obtained, a supplemental mdr 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.H3 other text : not returned - remains implanted.

• Brand Name: PERFIX PLUG
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11123017
• MDR Text Key: 225260359
• Report Number: 1213643-2020-20094
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608
• Combination Product (y/n): N
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0112760
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 108