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

Catalog Number	5955800
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during repair of a hernia defect on (b)(6) 2019, the patient was implanted with ventralight st mesh using echo ps, the surgeon did not close the defect and used tacks to make a double crown.As reported a few months later, the patient was diagnosed with a hernia recurrence directly in the middle of the mesh where the bowels were pushing through a new defect hole.On (b)(6) 2024, the patient underwent a reoperation by removing the completely peritonalized mesh.The hernia defect was closed with sutures and another ventralight st mesh was used to complete the repair.Reportedly the hole was in the middle of the mesh were the tubing of the echo ps goes through.It was noted upon review of the information provided that the mesh has a labeled expiration date on 28-oct-2018 and was implanted in (b)(6) 2019.This mdr represents implant of an expired mesh.
Additional Manufacturer Narrative
As reported, the patient was implanted with a ventralight st mesh using echo ps it was later identified that the mesh had expired.The expiration date is located on multiple layers of the packaging.This event is confirmed as a use related error, with no malfunction of the device.Review of manufacturing records shows product was manufactured to specification.This mdr represents the expired mesh implantation.An additional mdr was submitted to represent the post operative hernia recurrence.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.

• 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: 19460042
• Report Number: 1213643-2024-00286
• Device Sequence Number: 20814782
• Product Code: FTL
• UDI-Device Identifier: 00801741031779
• UDI-Public: (01)00801741031779
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 5955800
• Device Lot Number: HUAX1033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2016
• 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: Other
• Patient Age: 47 YR
• Patient Sex: Female