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

Catalog Number	0010101
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2009 ¿ patient was diagnosed with incisional hernia and bilateral inguinal hernias thereby underwent open repair with implant of two kugel hernia patch (device 1 and 2).Per operative notes, ¿an incisional hernia from the appendectomy site was reduced and closed primarily with sutures.In the left groin, the large direct defect was noted at internal ring and dissected.A kugel hernia patch (device 1) was placed and secured it with sutures.In the right groin, similarly a large defect was reduced and another kugel hernia patch (device 2) was placed and secured with sutures.¿ on (b)(6) 2014 ¿ patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with implant of perfix plug (device 3).Per operative notes, ¿in the left groin, the tissues were densely adherent to surrounding tissues.The mesh (device 1) was seen free entirely from inguinal ligament where the direct defect recurred.The hernia was dissected free and adhesions were lysed.The medium perfix plug (device 3) was placed over the hernia and previously placed mesh (device 1) was sutured to inguinal ligament and irrigated with sutures.¿ on (b)(6) 2016 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of bard flat mesh (device 4).Per operative notes, ¿ in the right groin, a moderately large lateral direct inguinal hernia was noted.The sac was dissected out circumferentially and floor was secured with sutures.A bard flat mesh (device 4) was placed over the inguinal floor and secured with sutures.¿ (note: the previously placed right inguinal mesh (device 2) was not seen during this procedure).
Additional Manufacturer Narrative
Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-sep-2008) is considered to be a best estimate.This mdr represents the kugel patch (device 2).An additional supplemental emdr was submitted to represent the bard/davol kugel patch (device 1).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: 23897315
• Report Number: 1213643-2025-01279
• Device Sequence Number: 14590686
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332(17)130928(10)HUSI1184
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2013
• Device Catalogue Number: 0010101
• Device Lot Number: HUSI1184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2008
• 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: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 99 KG