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

Catalog Number	5954600
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made as to the degree to which the bard device used to treat the patient may have caused or contributed to the reported hernia recurrence.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions-for- use as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.The information provided to date is limited.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Doctor reported that, umbilical hernia recurred at same site previously treated with ventralight st.
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made as to the degree to which the bard device used to treat the patient may have caused or contributed to the reported hernia recurrence.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions-for- use as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.The information provided to date is limited.Should additional information be provided, a supplemental emdr will be submitted.This is an addendum to document the date of implant and additional information indicating the mesh remains implanted and there has been no surgical intervention at this time.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Doctor reported that, umbilical hernia recurred at same site previously treated with ventralight st.Addendum: on (b)(6) 2019 - the patient underwent the repair of an umbilical hernia and was implanted with a bard ventralight st mesh.On (b)(6) 2019 - the patient experienced a hernia recurrence.The patient did not receive any additional surgical intervention at this time and the mesh remains implanted.

• Brand Name: VENTRALIGHT ST 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: 8914598
• Report Number: 1213643-2019-07319
• Device Sequence Number: 503119
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: 01/28/2020
• Device Catalogue Number: 5954600
• Device Lot Number: HUCN1771
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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
• Patient Age: 48 YR