MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5990011
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the echo 2 ps portion of the ventralight st w/ echo 2 ps was inadvertently left in the patient following mesh implant; the patient was taken back to the or and the portion was removed.No additional complications were reported.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 the device, ¿ventralight¿ st mesh is the only permanent implant component of the device.The echo 2¿ positioning system (which includes deployment frame, center hoisting suture and all connectors) must be removed from the patient and appropriately discarded.It is not part of the permanent implant.¿ "verify that the echo 2¿ positioning system frame is fully intact after removal, including all components listed (echo 2¿ positioning frame, connectors, suture) and discard appropriately." 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 : sample not returned.
Event or Problem Description
As per medwatch form, "patient to the or for ra (operating room for regional anesthesia) laparoscopic incisional umbilical hernia repair with bard 11.4cm ventralight mesh.While patient was in pacu (post-anesthesia care unit,), it was realized that the scaffold was not removed from the mesh during the initial procedure.Patient was taken back to the operating room for a diagnostic laparoscopy.The echo 2 scaffolding was identified and removed with luq (left upper quadrant) trochar.The physician carefully examined the scaffolding and it was determined to be intact.".

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 17867824
• Report Number: 1213643-2023-00356
• Device Sequence Number: 5493710
• Product Code: FTL
• UDI-Device Identifier: 00801741130977
• UDI-Public: (01)00801741130977
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

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: 05/28/2023
• Device Catalogue Number: 5990011
• Device Lot Number: HUGT0811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/04/2023
• 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