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

Catalog Number	0115814
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As alleged, the elastic ring (pet recoil ring) of the modified kugel mesh was found to be broken when opening the package.Due to contamination the subject device was not returned for evaluation.However, photos of the device were provided and reviewed.It is not clear in the photos if the ring is broken as alleged, as it cannot be visualized.Review of the photos provided cannot confirm or unconfirmed the reported broken ring or any condition that might have presented to the ring.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot (b)(4) released for distribution in july 2019.
Event or Problem Description
As reported, while opening the package of modified kugel mesh, it was noticed that the "elastic ring" (pet recoil ring) of the mesh was broken.It was reported that there was no physical damage identified to the sterile package and/or outer carton.It was also reported that the procedure completed using another modified kugel mesh.There was no reported patient injury.

• Brand Name: MODIFIED 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: 16652986
• Report Number: 1213643-2023-00132
• Device Sequence Number: 6500934
• Product Code: FTL
• UDI-Device Identifier: 00801741030819
• UDI-Public: (01)00801741030819
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963141
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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: 05/28/2024
• Device Catalogue Number: 0115814
• Device Lot Number: HUDR2301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• 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