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

Catalog Number	1190300
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); Raynauds Phenomenon (2034); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause of the patients reported post-op symptoms cannot be determined.No connection can be made between the reported events and the implant of the phasix mesh.A review of previous complaints 24 months found no similar complaints have been reported for the phasix mesh for an autoimmune reaction.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Allergic reaction is listed in the adverse reaction section of the instructions-for-use as a possible complication.Should additional information be provided, a supplemental emdr will be submitted.Device evaluated by mfr: remains implanted.
Event or Problem Description
Physician (cardiologist) who is currently seeing a patient who has presented with suspected auto-immune type symptoms inquired about the phasix mesh and if there are any known cases in which this mesh has been involved in causing or contributing to auto-immune disorders such as lupus or raynaud' phenomenon.As reported, per physician: the patient underwent implant of a phasix mesh approximately 6 months ago.The patient has since developed symptoms closely related to those of reynaud's phenomenon.Doctor has described symptoms of vasoreactivity in which the fingers are reacting when exposed to warm temperatures (vs.Cold temperature).The patient's blood serology was negative for lupus and there has been no definitive diagnosis made at this time.Doctor states he cannot rule out the mesh as a contributing factor as the patient does not have a history of auto-immune disorders or allergies.The doctor was not interested in a surgeon to surgeon consult at this time, although this was offered.Doctor also did not want to pursue a mesh skin patch test as he stated he did not feel that would be beneficial in this particular case.

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8568689
• Report Number: 1213643-2019-03535
• Device Sequence Number: 19249029
• Product Code: OOD
• UDI-Device Identifier: 00801741077685
• UDI-Public: (01)00801741077685
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: 08/28/2019
• Device Catalogue Number: 1190300
• Device Lot Number: HUBV0042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/01/2019
• 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: Required Intervention