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

Catalog Number	5954450
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by the customer to date requires clarification, and additional attempts have been made to obtain it.The sample is reported to be available for return; however, it has not yet been received.Based on the information reported and without access to the physical sample for evaluation, no conclusions can be drawn at this time.If and when the sample is returned and the evaluation is completed, a supplemental mdr will be submitted to document the results.A review of the manufacturing records was performed and confirmed that the lot was manufactured according to specifications.To date, this is the only reported complaint associated with this manufacturing lot of (b)(4) units.This mdr represents lot number hujp1924 an additional mdr was submitted to represent lot number hukq0676.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.
Event or Problem Description
As reported: ¿after opening the box, a yellow paper-like foreign object was found inside¿ (lot numbers hukq0767 and hujp1924).Additional follow-up information states: ¿regarding the foreign material, it is confirmed that what appears to be a relic (scratch?) is present on the bag inside the sterilization packaging and in the center of the mesh of hukq0767.¿ no patient injury was reported.
Additional Manufacturer Narrative
The information provided by the customer to date requires clarification, and additional attempts have been made to obtain it.The sample is reported to be available for return; however, it has not yet been received.Based on the information reported and without access to the physical sample for evaluation, no conclusions can be drawn at this time.If and when the sample is returned and the evaluation is completed, a supplemental mdr will be submitted to document the results.A review of the manufacturing records was performed and confirmed that the lot was manufactured according to specifications.To date, this is the only reported complaint associated with this manufacturing lot of 420 units.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.A visual examination finds there is "foreign" material (yellow in color) that has been taped by the user to the inside of the tyvek envelope.Based on visual and manufacturing process evaluation performed, discrepancy reported could be matched with a manufacturing generated condition.The foreign matter evaluated could be associated with a casting material remnant residue.Awareness notification was provided to all manufacturing personnel from sepramesh manufacturing area on event reported, with emphasis on visual inspection acceptance criteria requirements.This supplemental mdr represents lot number hujp1924 (1213643-2025-01075).An additional supplemental mdr was submitted to represent lot number hukq0767 (1213643-2025-01076).Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.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.
Event or Problem Description
As reported: ¿after opening the box, a yellow paper-like foreign object was found inside¿ (lot numbers hukq0767 and hujp1924).Additional follow-up information states: ¿regarding the foreign material, it is confirmed that what appears to be a relic (scratch?) is present on the bag inside the sterilization packaging and in the center of the mesh of hukq0767.¿ no patient injury was reported.

• Brand Name: VENTRALIGHT ST MESH
• 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: 23496891
• Report Number: 1213643-2025-01075
• Device Sequence Number: 8867663
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(11)240301(17)260228(10)HUJP1924
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 02/28/2026
• Device Catalogue Number: 5954450
• Device Lot Number: HUJP1924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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 Sex: Unknown