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

Catalog Number	5955113
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Recurrence of the hernia or soft tissue defect is a known complication of hernia repair surgery and is listed in the adverse reactions section of the instructions for use, supplied with the device.Evaluation of photos provided confirmed the reported condition but do not allow for any conclusion to be made as to the cause of the patient's post-op hernia recurrence.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 71 units released for distribution in (b)(6) 2020.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 - sample discarded.
Event or Problem Description
A patient underwent a laparoscopic repair of midline multi-recurrent complex ventral (incisional) hernia 15cm x 23cm with multiple defects on(b)(6) 2020.A ventralight st w/echo ps was used for the repair.Surgeon reports on (b)(6) 2023 the patient had a hernia recurrence.Surgeon noted the mesh has split in midline.The caudal edge was floating free from the abdominal wall.The cranial edge was secure.The left and right sides were attached.The lower midline suture line was also disrupted.Per surgeon, ¿i am not entirely sure why the midline mesh and suture repair has failed.I don¿t think any mesh was salvaged¿ (for evaluation/ return).

• 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: 17181382
• Report Number: 1213643-2023-00242
• Device Sequence Number: 6809539
• Product Code: FTL
• UDI-Device Identifier: 00801741031694
• UDI-Public: (01)00801741031694
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 06/06/2023

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: 01/28/2022
• Device Catalogue Number: 5955113
• Device Lot Number: HUDZ2074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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 Age: 58 YR
• Patient Sex: Male