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

Catalog Number	5959480
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when staff opened the outer box of the sepramesh ip mesh the inner package was found to be damaged.It was reported that they did not continue to use the product for fear of contamination.Another mesh was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, sepramesh ip inner package was damaged.Photos and a video were provided for review.Evaluation shows the pouch has been opened and there is wrinkling present where the vendor seal has been opened on both the left and right sides of the pouch.Photos and video do not assist in determining root cause.The physical sample has been received for evaluation.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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.
Additional Manufacturer Narrative
As reported, sepramesh ip inner package was damaged.Photos and a video were provided for review.Evaluation shows the pouch has been opened and there is wrinkling present where the vendor seal has been opened on both the left and right sides of the pouch.Photos and video do not assist in determining root cause.The physical sample has been received for evaluation.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 108 units.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the sample evaluation.Evaluation of the sample finds that side seals on one side of the pouch showed some elongation/curling after peeling (opening).This can happen during the opening process based on the opening technique used.This occurrence does not affect sterility or compromise the sterile transfer.Inspection of the entire pouch and sealing area indicated that the pouch was sealed correctly, and the pouch integrity was intact with wrinkling present on the foil pouch where the seal has been opened.Examination of the seal confirms there was no breach to the package prior to opening.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, when staff opened the outer box of the sepramesh ip mesh the inner package was found to be damaged.It was reported that they did not continue to use the product for fear of contamination.Another mesh was used to complete the procedure.There was no patient injury.

• Brand Name: SEPRAMESH IP
• 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: 21851490
• Report Number: 1213643-2025-00327
• Device Sequence Number: 8817640
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816(11)240223(17)260128(10)HUJP1204
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 01/28/2026
• Device Catalogue Number: 5959480
• Device Lot Number: HUJP1204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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