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

Catalog Number	5950060
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient reports having seen multiple doctors and no diagnosis has been made as to the cause of her symptoms.Based on the information provided at this time, no conclusion can be made as to the degree to which the mesh implant may be causing or contributing to the reported patient symptoms.Additional information has been requested.Should additional information be provided, a supplemental mdr will be submitted.No lot number has been provided, there for a review of the manufacturing records cannot be conducted at this time.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.Remains implanted.
Event or Problem Description
The following was reported to davol: on (b)(6) 2015 - the patient underwent repair of the large recurrent hernia.During this procedure it is reported that the patient was implanted with a bard ventrio st hernia patch.As reported, postoperatively the patient experienced abdominal wound dehiscence and wound healing complications.The patient underwent extensive wound care treatments to heal her abdominal wound.As reported the patient has been experiencing chronic abdominal pain since the 2015 hernia repair.The pain is reported to be intermittent and the patient can feel "in four corners of her stomach sharp pain." also reported is labored breathing, nausea and frequent bowel issues (diarrhea).The patient has to frequently call out sick from work due to her symptoms.The patient has seen multiple doctors regarding the reported issues.She had 2 ct scans performed which had no findings.The patient has been evaluated for infections and those reports are negative as well.As reported the doctors do not know what is contributing to the reported issues.The contact stated that the patient is very depressed from experiencing all these issues and has been put on an antidepressant from her doctor and also has been prescribed prescription pain medication for the pain, which she takes as needed.

• 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: 6692830
• Report Number: 1213643-2017-00387
• Device Sequence Number: 16336623
• Product Code: FTL
• UDI-Device Identifier: 00801741031557
• UDI-Public: (01)00801741031557
• Combination Product (Y/N): N
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

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 Catalogue Number: 5950060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/07/2017
• 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
• Patient Age: 70 YR