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

Catalog Number	5950070
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rash (2033); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the limited information provided, no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the patient outcome.Photos were provided of the patient's back, arms and legs showing what appears to be a rash.Multiple attempts have been made to follow up with the contact, however to date there has been no response.At this time, no conclusion can be made.Allergic reaction is identified in the instructions-for-use, provided with the device as a possible complication.A lot number was not provided; without a lot number a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
It was reported via an email message that the patient developed an allergic reaction (rash) following implant of a bard ventrio st mesh.As reported the patient is questioning if the cause of their possible lupus and or vasculitis is linked to the mesh.As reported the patient has no known allergies.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9293283
• Report Number: 1213643-2019-10788
• Device Sequence Number: 1864551
• Product Code: FTL
• UDI-Device Identifier: 00801741031564
• UDI-Public: (01)00801741031564
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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 Catalogue Number: 5950070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2019
• Initial Report FDA Received Date: 11/07/2019
• 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