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

Model Number 5955600

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

As reported, during a laparoscopic umbilical hernia repair procedure on (b)(6) 2022.The bard/davol ventralight st w/echo ps mesh was used.As reported, the surgeon removed the echo ps balloon after fixating the mesh and the or team found that one connector was missing.It was reported that the surgeon then noticed the coil slightly sticking out of the mesh and removed it with a grasper successfully.As reported, the surgeon grasped the balloon at the dark arrow marked on the balloon and pulled as directed.As reported, there was no patient harm or injury as a result.

Manufacturer Narrative

As reported the sample is not available for return.Based on the information provided and without having the sample to evaluate, no conclusions can be made.To date, this is the only reported complaint for this manufacturing lot.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Type of Device: 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: 15968681
• MDR Text Key: 307692713
• Report Number: 1213643-2022-00786
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5955600
• Device Catalogue Number: 5955600
• Device Lot Number: HUGT1990
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other