MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PHASIX PLUG AND PATCH; SURGICAL MESH

Catalog Number	1190600
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rash (2033); Discomfort (2330); Reaction (2414)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information currently available we are unable to determine a correlation between the reported rash and discomfort and the bard mesh used to treat the patient.A sample mesh will be provided to the patient's dermatologist for reactivity testing.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august 2019.The instructions-for-use (ifu) supplied with the device states: "in pre-clinical testing, phasix¿ plug and patch elicited a minimal foreign body response.The tissue reaction resolved as the mesh was resorbed." the phasix¿ plug and patch is a resorbable mesh and nearly complete at 12 to 18 months.When/if the result of the reactivity testing are provided, a supplemental emdr will be submitted to document the results provided.Not returned: device remains implanted.
Event or Problem Description
It was reported that on (b)(6) 2019, during a ventral hernia repair, the patient was implanted with a bard/davol phasix plug and patch and post surgery the patient showed signs of discomfort, rash and irritation around the surgical site.As reported, the surgeon thought this to be related to the topicals (skin prep etc.) used during the surgical procedure, however, the rash did not resolve as it was expected to.The rash is localized in the area of the mesh and the patient is now under the care of a dermatologist.A sample of the mesh has been requested to perform a reactivity test.
Event or Problem Description
It was reported that on 18-dec-2019, during a ventral hernia repair, the patient was implanted with a bard/davol phasix plug and patch and post surgery the patient showed signs of discomfort, rash and irritation around the surgical site.As reported, the surgeon thought this to be related to the topicals (skin prep etc.) used during the surgical procedure, however, the rash did not resolve as it was expected to.The rash is localized in the area of the mesh and the patient is now under the care of a dermatologist.A sample of the mesh has been requested to perform a reactivity test.Addendum: reactivity testing was performed and it was confirmed the reactivity test had a negative result to the mesh.
Additional Manufacturer Narrative
Based on the information currently available we are unable to determine a correlation between the reported rash and discomfort and the bard mesh used to treat the patient.A sample mesh will be provided to the patient's dermatologist for reactivity testing.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 134 units released for distribution in august 2019.The instructions-for-use (ifu) supplied with the device states: "in pre-clinical testing, phasix¿ plug and patch elicited a minimal foreign body response.The tissue reaction resolved as the mesh was resorbed." the phasix¿ plug and patch is a resorbable mesh and nearly complete at 12 to 18 months.Addendum: this is an addendum to the initial emdr submitted to document the results of the reactivity testing.Reactivity testing has been performed and as reported the results were negative for an allergic response to the mesh sample.It is unknown at this time, what is causing the patient's condition.However, based on testing performed the postoperative condition does not appear to be caused by the bard/davol mesh used to treat the patient.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.

• Brand Name: PHASIX PLUG AND PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10483191
• Report Number: 1213643-2020-07793
• Device Sequence Number: 2816758
• Product Code: OWT
• UDI-Device Identifier: 00801741010606
• UDI-Public: (01)00801741010606
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K120728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: 06/28/2021
• Device Catalogue Number: 1190600
• Device Lot Number: WBDT0053
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR