MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO; SURGICAL MESH

Catalog Number	5955113
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The maude event report did not include any contact information for the patient; therefore no attempts for additional information can be made at this time.Based on the limited information that has been provided to date, we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged.Should additional information be provided, a supplemental mdr will be submitted.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions for use as a possible complication.Additionally, the warning section states, "to prevent recurrences when repairing hernias, it is recommended that the prosthesis be large enough to extend to at least 3 to 5 cm beyond the margins of the defect." the information provided by bard 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 bard.Remians implanted.
Event or Problem Description
The following was reported via maude event report (mw5071859): "had hernia repair.They used ventralight st mesh with echo ps positioning system.The mesh was faulty, as i now have another hernia in same place, with constant discomfort.When it rips i get terrible pain.I have been told by dr's that they will not operate on it again until it becomes life threatening.This mesh has caused so much pain and discomfort.".

• Brand Name: VENTRALIGHT ST W/ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6912042
• Report Number: 1213643-2017-00647
• Device Sequence Number: 13617046
• Product Code: FTL
• UDI-Device Identifier: 00801741031694
• UDI-Public: (01)00801741031694(17)150331(10)HUXC1394
• Combination Product (Y/N): N
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2017

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: 03/31/2015
• Device Catalogue Number: 5955113
• Device Lot Number: HUXC1394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/03/2017
• 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