MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number	5955460
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the echo ps portion of the ventralight st w/ echo ps device was inadvertently left in the patient following mesh implant; the patient underwent subsequent surgical intervention for the removal for echo ps.Based on the information provided the reported event is determined to be use related with no malfunction of the device as the instructions-for-use were not followed.Per the instructions-for-use, supplied with this device, "once initial mesh fixation is complete, the echo ps positioning system is completely removed from the body.The echo ps positioning system (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant.The information provided by bd 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 bd.Not returned.
Event or Problem Description
As reported, during a laparoscopic umbilical hernia repair procedure on (b)(6) 2022, a bard/davol ventralight st mesh w/ echo ps was implanted in the patient.As reported, when the case was completed, the or circulator identified that the echo ps was not removed from the patient.As reported, the patient was taken back into the or on the same day and the echo ps was removed without any further issue.
Event or Problem Description
As reported, during a laparoscopic umbilical hernia repair procedure on 05-oct-2022, a bard/davol ventralight st mesh w/ echo ps was implanted in the patient.As reported, when the case was completed, the or circulator identified that the echo ps was not removed from the patient.As reported, the patient was taken back into the or on the same day and the echo ps was removed without any further issue.
Additional Manufacturer Narrative
As reported, the echo ps portion of the ventralight st w/ echo ps device was inadvertently left in the patient following mesh implant; the patient underwent subsequent surgical intervention for the removal for echo ps.Based on the information provided the reported event is determined to be use related with no malfunction of the device as the instructions-for-use were not followed.Per the instructions-for-use, supplied with this device, "once initial mesh fixation is complete, the echo ps positioning system is completely removed from the body.The echo ps positioning system (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document a correction to the annex b codes.Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 15690009
• Report Number: 1213643-2022-00676
• Device Sequence Number: 15130330
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

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: 04/28/2024
• Device Catalogue Number: 5955460
• Device Lot Number: HUGS0525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown