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

Catalog Number	1160610
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, xenmatrix surgical graft outer package of the patch was damaged.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.
Event or Problem Description
As reported, on 18-apr-2025 when the xenmatrix surgical graft was opened it was found that the outer package of the patch was damaged.There was no patient injury.
Event or Problem Description
As reported, on (b)(6) 2025 when the xenmatrix surgical graft was opened it was found that the outer package of the patch was damaged.There was no patient injury.
Additional Manufacturer Narrative
As reported, xenmatrix surgical graft outer package of the patch was damaged.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)(6) units.Addendum: this is an addendum to the initial mdr submitted to document the results of device evaluation.Visual examination of the returned sample revealed a small tear/hole present on the backside of the foil pouch.There was no corresponding damage to the carton.This suggests that the pouch was most likely damaged while outside of the carton.Evaluation found the condition did not yield a sterile barrier breach as the condition was limited to the foil pouch, the graft device is contained within an inner sterile pouch which was not damaged.Based on the evaluation of the received sample condition and the device history record assessment, it is possible that the reported condition occurred after the product had completed the manufacturing activities.The investigation could not confirm an exact reason, as multiple control points within the xenmatrix manufacturing process that are capable of detecting sealing discrepancies of the type reported during production.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.Corrected field: h4.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: XENMATRIX
• Common Device Name: PORCINE 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: 22185052
• Report Number: 1213643-2025-00464
• Device Sequence Number: 18315554
• Product Code: FTM
• UDI-Device Identifier: 00801741074349
• UDI-Public: (01)00801741074349(17)260528(10)HUJT0274
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140501
• 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): 06/12/2025

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: 05/28/2026
• Device Catalogue Number: 1160610
• Device Lot Number: HUJT0274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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