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

Catalog Number UNKAA111

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Foreign Body In Patient (2687); Unspecified Musculoskeletal problem (4535)

Event Date 10/10/2022

Event Type  Injury  

Event Description

As reported, during an unspecified procedure, the ventralight st w/echo 2 positioning system was left inside the patient¿s body.It was reported that another surgeon noted the device and agreed to remove the echo ps.As reported under imaging the device appears to be metallic.Contact reports the patient has pain and mobility issues and is concerned about having an mri performed.

Manufacturer Narrative

As reported, the echo 2 ps portion of the ventralight st w/ echo 2 positioning system was inadvertently left in the patient following mesh implant.It is reported that the patient will require subsequent surgical intervention for removal of the echo 2 ps.Based on the information provided the reported event is determined to be use related as the instructions-for-use were not followed.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Per the instructions for use (ifu) supplied with this 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." note, the date of event provided is a best estimate based on the date of awareness of the reported event.Not returned - remains implanted.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 15713666
• MDR Text Key: 302830056
• Report Number: 1213643-2022-00691
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2022
• 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): Required Intervention
• Patient Sex: Male