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

Catalog Number	0010101
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the kugel patch ruptured (tore) while being inserted with a retractor.Per information reported, kugel technique was performed without a trocar.A new mesh was then inserted using the same method and the procedure was completed without further issues.It was reported that the inner packaging and the mesh was intact prior to use.There was no patient injury.
Additional Manufacturer Narrative
As reported, the kugel patch was ruptured (torn) during insertion.The physical sample is expected to be returned for evaluation; however, it has not yet been received.Based on the information currently available and without the sample for analysis, no conclusions can be made at this time.If and when the sample is returned and evaluated, a supplemental mdr will be submitted to document the evaluation results.A review of manufacturing records confirms that the lot was manufactured according 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, the kugel patch ruptured (tore) while being inserted with a retractor.Per information reported, kugel technique was performed without a trocar.A new mesh was then inserted using the same method and the procedure was completed without further issues.It was reported that the inner packaging and the mesh was intact prior to use.There was no patient injury.
Additional Manufacturer Narrative
As reported, the kugel patch was ruptured (torn) during insertion.The physical sample is expected to be returned for evaluation; however, it has not yet been received.Based on the information currently available and without the sample for analysis, no conclusions can be made at this time.If and when the sample is returned and evaluated, a supplemental mdr will be submitted to document the evaluation results.A review of manufacturing records confirms that the lot was manufactured according to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.Evaluation of the sample confirms the reported event.Based on the sample condition and the reported event the likely root cause is that the mesh was inadvertently damaged during attempting placement.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.

• Brand Name: KUGEL PATCH
• 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: 23881250
• Report Number: 1213643-2025-01258
• Device Sequence Number: 9605704
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332(17)291028(10)HUJY1007
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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 Catalogue Number: 0010101
• Device Lot Number: HUJY1007
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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