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

Catalog Number	0115808
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Fistula (1862); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	02/05/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges general allegations for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.\not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for the implant of an unspecified bard/davol modified kugel hernia patch on (b)(6) 2006.As reported, the patient is making a claim for an adverse patient outcome against modified kugel hernia patch.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges general allegations for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided and to correct pma/510(k) #.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.Updated fields: a2, a4, b2, b3, b4, b5, b6, b7, d4, d.6b (date of explant), g3, g6, h2, h4, h6, h10, h11.Corrected fields : g4 (pma/510(k) #) 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
Attorney alleges that the patient underwent surgery for the implant of an unspecified bard/davol modified kugel hernia patch on (b)(6) 2006.As reported, the patient is making a claim for an adverse patient outcome against modified kugel hernia patch.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: on (b)(6) 2006 ¿ patient was diagnosed with recurrent right inguinal hernia repair thereby underwent open repair with implant of modified kugel hernia patch.Per operative notes, ¿the patient was noted to have medial direct hernia.A modified kugel patch was placed in the preperitoneal space and secured in place using sutures.¿ on (b)(6) 2014 ¿ patient was diagnosed with infected right groin mesh, recurrent right inguinal hernia thereby underwent open repair with an removal of mesh.Per operative notes, ¿the medial portion of infected mesh and lateral portion of incorporated mesh were removed.There was a fistula tract going through the abscess at the base of the penis.The modified kugel patch (device # 1) was removed completely and the tract was excised.A biological mesh was placed and secured medially to lateral border of the rectus muscle, inferiorly with the pubic tubercle and laterally to the inguinal ligament using sutures.¿.

• 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 ; 4018258495
• MDR Report Key: 9817695
• Report Number: 1213643-2020-02348
• Device Sequence Number: 3068796
• Product Code: FTL
• UDI-Device Identifier: 00801741030789
• UDI-Public: (01)00801741030789(10)43BQD600
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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 Catalogue Number: 0115808
• Device Lot Number: 43BQD600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Disability; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 68 KG