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

Catalog Number	5954600
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Adhesion(s) (1695); No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No conclusion can be made.Based on the information provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.The information provided is limited at this time, additional information has been requested.A lot number was not provided, therefore a review of the manufacturing records is not possible.Adhesions are a known inherent risk of surgery and are 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.Not returned.
Event or Problem Description
It was reported that a previously place bard ventralight st mesh was found to be " sticking to the intestines which may have caused complications, thus was removed and discarded.".
Additional Manufacturer Narrative
This is an addendum to the initial emdr as additional information provided brings clarification to the event.Due to the surgeon noting during the index procedure that the "mesh was sticking to the intestine" the surgeon took a precautionary measure, to avoid the possibility of a serious injury in the future and did not implant the mesh into the patient.There was no additional intervention or injury to the patient.The sample was not returned for evaluation as such cannot be evaluated for root cause analysis.The initial determination remains the same, no conclusion can be made.
Event or Problem Description
It was reported that a previously place bard ventralight st mesh was found to be " sticking to the intestines which may have caused complications, thus was removed and discarded." addendum: contact reported that the problem presented during the index procedure of the bard ventralight st mesh.The doctor noted that once placed at the site it was sticking on the intestine.The surgeon was not confident in using the device and it was removed and another was used.There was no patient injury.

• 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: 8177427
• Report Number: 1213643-2018-04861
• Device Sequence Number: 19097141
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5954600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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